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NCT Number: NCT06267365

Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

This is an observational prospective study to develop predictive biomarkers for pain response in participants with chronic pancreatitis scheduled for endoscopic therapy. Participants will undergo baseline assessments including electroencephalography (EEG), quantitative sensory testing (QST), and psychosocial questionnaires. Response to endoscopic therapy will be assessed at approximately 3, 6, 12 and 18 months post-procedure using questionnaires.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults older than 18 years;
  • Cambridge III or IV criteria for Chronic Pancreatitis (CP); or M-ANNHEIM criteria for definitive chronic pancreatitis;
  • scheduled for endoscopic therapy for ductal obstruction (may include lithotripsy, pancreatic duct dilation, or stone extraction to facilitate successful stenting) as part of routine clinical care based on multidisciplinary review;
  • pain present for ≥ 3 days per week for ≥ 3 months;
  • average pain over the last week ≥ 4 on a 11-point numeric rating scale (NRS).

Exclusion criteria

  • chronic pain syndrome other than CP;
  • episode of acute pancreatitis within 2 months of enrollment;
  • endoscopic therapy including Endoscopic retrograde cholangiopancreatography (ERCP), Endoscopic ultrasound (EUS) Guided Celiac Plexus Block or pancreatic surgery < 6 months prior to enrollment;
  • active illicit drug use (excludes marijuana use);
  • American Society of Anesthesiologists classification > 3;
  • immune-mediated pancreatitis or associated pancreatic neoplasms
  • Major neurological disease such as stroke, uncontrolled epilepsy, dementia
  • Diagnosis of schizophrenia
  • Chronic benzodiazepine use. Use of short acting benzodiazepine on as needed basis is acceptable if participant is able to hold benzodiazepine prior to EEG recording.
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation

    Time frame: Baseline, Month 3 Post-Operation

    BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.

Secondary outcomes

  1. Change from Baseline in BPI Score at Month 6 Post-Operation

    Time frame: Baseline, Month 6 Post-Operation

    BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.

  2. Change from Baseline in BPI Score at Month 12 Post-Operation

    Time frame: Baseline, Month 12 Post-Operation

    BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.

  3. Change from Baseline in BPI Score at Month 18 Post-Operation

    Time frame: Baseline, Month 18 Post-Operation

    BPI is a 9-item assessment of pain. Each item is rated on a Likert scale from 0 (No Pain) to 10 (Pain as bad as you can imagine). The total score is the sum of responses and ranges from 0-90; higher scores indicate greater pain.

  4. Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation

    Time frame: Baseline, Month 3 Post-Operation

    The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.

  5. Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation

    Time frame: Baseline, Month 6 Post-Operation

    The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.

  6. Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation

    Time frame: Baseline, Month 12 Post-Operation

    The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.

  7. Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation

    Time frame: Baseline, Month 18 Post-Operation

    The PROMIS Physical Function Short Form 6b comprises 6 questions assessing general physical function. Each item is rated on a Likert scale from 1 (Unable to do) to 5 (Without any difficulty). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater physical function.

  8. Number of Participants who use Opioids at Baseline

    Time frame: Baseline

  9. Number of Participants who use Opioids at Month 3

    Time frame: Month 3

  10. Number of Participants who use Opioids at Month 6

    Time frame: Month 6

  11. Number of Participants who use Opioids at Month 12

    Time frame: Month 12

  12. Number of Participants who use Opioids at Month 18

    Time frame: Month 18

  13. Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.

  14. Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.

  15. Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.

  16. Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    The PROMIS Depression - Short Form 4a is a 4-item assessment of symptoms of depression in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of depressive symptoms.

  17. Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.

  18. Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.

  19. Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.

  20. Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    The PROMIS Anxiety- Short Form 4a is a 4-item assessment of symptoms of anxiety in the past 7 days. Items are ranked on a Likert scale from 1 (never) to 5 (always). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of anxiety.

  21. Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.

  22. Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.

  23. Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.

  24. Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    The PROMIS Neuropathic Pain Quality 5a is a 5-item assessment of symptoms of neuropathic pain in the past 7 days. Items are ranked on a Likert scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of neuropathic pain.

  25. Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.

  26. Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.

  27. Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.

  28. Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    The PROMIS Sleep Disturbance - Short Form 6a is a 6-item assessment of sleep disturbance in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of sleep disturbance.

  29. Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.

  30. Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.

  31. Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.

  32. Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    The PROMIS Fatigue - Short Form 6a is a 6-item assessment of fatigue in the past 7 days. Items are ranked on a Likert scale from 1-5. The raw score is the sum of responses and is transformed into a T-score a mean of 50 and standard deviation of 10. Scores range from 0-100; higher scores indicate greater prevalence of fatigue.

  33. Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.

  34. Change from Baseline in PCS Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.

  35. Change from Baseline in PCS Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.

  36. Change from Baseline in PCS Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    The PCS is a 13-item assessment of the prevalence of thoughts and feelings associated with pain. Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate greater pain catastrophizing.

  37. Change from Baseline in Sleep Duration at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

  38. Change from Baseline in Sleep Duration at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

  39. Change from Baseline in Sleep Duration at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

  40. Change from Baseline in Sleep Duration at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

  41. Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.

  42. Change from Baseline in TAPS Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.

  43. Change from Baseline in TAPS Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.

  44. Change from Baseline in TAPS Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    TAPS consists of a combined screening component (TAPS-1) followed by a brief followed by a brief assessment (TAPS-2) for those who screen positive. Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use.

  45. Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.

  46. Change from Baseline in PGIC Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.

  47. Change from Baseline in PGIC Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.

  48. Change from Baseline in PGIC Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    PGIC is a 1-item assessment of patient's perception of the change in activity limitation, symptoms, emotions and overall quality of life related to their condition since beginning treatment. The item is rated on a scale from 1 (no change) to 7 (a great deal better). The final score is the numerical rating; higher scores indicate greater change.

  49. Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.

  50. Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.

  51. Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.

  52. Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    PHQ-2 is a 2-item assessment of patient health in the last 2 weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 6; lower scores indicate better health.

  53. Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.

  54. Change from Baseline in GAD-2 Score at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.

  55. Change from Baseline in GAD-2 Score at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.

  56. Change from Baseline in GAD-2 Score at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    GAD-2 is a 2-item assessment of symptoms of anxiety in the past two weeks. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day).The total score is the sum of responses and ranges from 0-6; higher scores indicate greater symptoms of anxiety.

  57. Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure

    Time frame: Baseline, Month 3 Post-Procedure

    PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.

  58. Change from Baseline in PEG Scale at Month 6 Post-Procedure

    Time frame: Baseline, Month 6 Post-Procedure

    PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.

  59. Change from Baseline in PEG Scale at Month 12 Post-Procedure

    Time frame: Baseline, Month 12 Post-Procedure

    PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.

  60. Change from Baseline in PEG Scale at Month 18 Post-Procedure

    Time frame: Baseline, Month 18 Post-Procedure

    PEG is a 3-item assessment of pain and how it interferes with activities of daily life. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the 3 items and ranges from 0-10; higher scores indicate greater pain interference.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Doan, MD

CONTACT

[email protected]

212-263-5072

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 20, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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