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NCT Number: NCT03625752

Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

The purpose of this study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetic Neuropathies Chronic Pain Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ciro Ramos Estebanez, Chicago, Illinois, United States

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About this study

Active stimulation will be compared with compared to SHAM stimulation in DNP patients.

20 DNP patients, 10 per group, receive stimulation or sham for 5 consecutive days, 20 min/day, followed by 2, 4, and 6 weeks post-therapy. 9 visits plus screening/baseline (total 10 visits).

Subsequently, 40 DNP patients will be enrolled, 20 per group, giving 5 consecutive days, 20 min/day, followed by 2 weeks of bi-weekly stimulation or sham for 20 min/day (total stimulations n=9) and follow-ups at 2, 4, 6, & 8 weeks post-stim): 13 visits plus screening/ baseline (total 14 visits).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to provide informed consent to participate in the study.
  • Subjects between 40 to 80 years old.
  • Having diabetic neuropathic pain, involving at least 1 foot, with existing pain for at least 6 months, and having pain on at least half the days in the past 6 months with an average of at least a 4 on a 0-10 VAS scale).
  • Having pain resistant to common analgesics and medications for first-line therapy of chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, Codeine, etc.
  • Must have the ability to feel pain as self-reported.

Exclusion criteria

  • Subject is pregnant.
  • Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
  • History of alcohol or drug abuse within the past 6 months as self-reported.
  • Use of carbamazepine within the past 6 months as self-reported.
  • Suffering from severe depression (with a PHQ 9 score of ≥ 10).
  • History of neurological disorders as self-reported.
  • History of unexplained fainting spells as self-reported.
  • History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.
  • History of neurosurgery as self-reported.
  • Unstable pain (defined as pain intensities that vary by more than 4 points on 0-10 VAS scale over the 1-week period of trial run-in).

Treatment and study plan

Active Comparator: Active tDCS + Active TUS

Device

Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

SHAM

Device

Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Primary outcomes

  1. Changes in pain as measured by the Visual Analog Scale (VAS)

    Time frame: Measured for approximately 3 months

    The scale will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable). Changes in VAS for Pain will be measured to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.

Secondary outcomes

  1. Changes in the Verbal Rating Scale (VRS) for Pain

    Time frame: Measured for approximately 3 months

    The VRS for Pain is a categorical scale of pain with categories: none, mild, moderate, severe pain intensity. Changes in VRS for Pain will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction. with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.

  2. Changes in Conditional Pain Modulation

    Time frame: Measured for approximately 3 months

    Changes in Conditional Pain Modulation (CPM) will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in increasing the pain pressure threshold in subjects with diabetic neuropathic pain.

  3. Changes in Visual Analog Scalefor Mood (VAMS)

    Time frame: Measured for approximately 3 months

    The VAS for Mood will investigate Anxiety, Depression, Stress, and Sleepiness. The Subscales are as follows:

    The anxiety scale will assess a patient's anxiety on a scale from 0 (not anxious) to 10 (very anxious).

    The depression scale will assess a patient's depression on a scale from 0 (not depressed) to 10 (very depressed).

    The stress scale will assess a patient's stress on a scale from 0 (not stressed) to 10 (very stressed).

    The sleepiness scale will assess a patient's depression on a scale from 0 (not sleepy) to 10 (very sleepy).

  4. Montreal Cognitive Assessment

    Time frame: Measured for approximately 3 months

    The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition. Scores range from lowest being 0 to highest being 30.

  5. 4-choice reaction time

    Time frame: Measured for approximately 3 months

    This is an attentional task that measures the time for a subject response to stimuli (in seconds) with shorter times being better.

  6. N-back tests

    Time frame: Measured for approximately 3 months

    Assesses registration and immediate recall on a scale of the number of items correctly responded to

  7. Electroencephalography

    Time frame: Measured for approximately 3 months

    Investigators will measure electroencephalogram (EEG) electrical activity (EEG amplitude and EEG frequency) as function of time.

  8. Walking test

    Time frame: Measured for approximately 3 months

    The investigators will measure if there are changes in the walking speed, gait asymmetry, stride length, and walking smoothness of the subject from the beginning of the study to the end

  9. Functional reach test

    Time frame: Measured for approximately 3 months

    The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.

  10. Study 36-Item Short Form (SF-36)

    Time frame: Measured for approximately 3 months

    This is a health survey using a scale from 0 (worst) to 100 (best)

  11. Patient Health Questionnaire (PHQ-9)

    Time frame: Measured for approximately 3 months

    This questionnaire screens for depression with a score of 0 (best) to 27 (worst)

  12. American Pain Foundation Pain and Medication Diary

    Time frame: Measured for approximately 3 months

    The pain sub-scale measures pain intensity from 0 (best) to 10 (worst)

  13. Multidimensional Pain Inventory (MPI)

    Time frame: Measured for approximately 3 months

    This pain scale measures aspects of pain from 0 (best) to 6 (worst)

  14. Brief Pain Inventory-DPN

    Time frame: Measured for approximately 3 months

    This pain scale measures aspects of pain from 0 (no pain) to 10 (worst)

  15. Adverse events

    Time frame: Measured for approximately 3 months

    At each session after stimulation begins, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale (0 being best and 5 worst). The scale will also be administered at the follow-up.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • Highland Instruments, Inc.

Registry information

Official study title

Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2018
Registry last updated
Jun 29, 2026

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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