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NCT Number: NCT06510725

Effect of Multitarget tDCS for Neuropathic Pain

This study aims to conduct a randomized controlled trial to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) on pain, depression, anxiety, quality of life and sleep, in patients with neuropathic pain.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The present multicenter, randomized, double-blind, sham-controlled, parallel-group trial aims to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) in patients with neuropathic pain.

The patients will be randomized to receive one of 3 treatment arms: multitarget stimulation, single-target stimulation and sham stimulation. All patients received 20 minutes of active or sham tDCS once a day for 10 consecutive weekdays. In multitarget group, subjects will receive 2mA tDCS applied to M1 and DLPFC alternately, with each target stimulated for 5 sessions. In single-target group, 2mA tDCS will target M1 only. In sham group, subjects will receive sham tDCS. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female or males aged between 18 and 75 years.
  • Pain fulfilling the criteria for probable or definite neuropathic pain and scoring ≥4/10 at Douleur Neuropathique 4 Questions.
  • Pain duration of at least 3 months and average pain intensity scoring ≥4/10 at Numeric Rating Scale.
  • Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial.
  • Informed consent obtained.

Exclusion criteria

  • Pregnancy or lactation.
  • Active central nervous system diseases including but not limited to brain tumour, intracranial hypertension, past or current epilepsy.
  • Unable to complete the questionnaire due to language abilities or reduced cognitive functioning.
  • Alcohol or substance abuse.
  • Common contraindications for transcranial direct current stimulation including but not limited to skull defect, implanted device or metal in the brain, severe cardiopulmonary, renal or hepatic diseases.
  • Unwilling to comply with the treatment or follow-up assessments.
  • Participating in another clinical trial within 3 months prior to enrollment of this clinical trial.
  • Any patient deemed unsuitable for enrollment by the investigators.

Treatment and study plan

Mutitarget tDCS

Device

Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to DLPFC and M1 alternately for ten consecutive weekdays, with each target stimulated for 5 sessions.

Single-target tDCS

Device

Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays.

Sham tDCS

Device

Subjects will receive 20 minutes of sham transcranial direct current stimulation. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps. Subjects will undergo stimulation once a day for ten consecutive weekdays.

Primary outcomes

  1. Change in average pain intensity

    Time frame: from baseline to week 2

    Change in average pain intensity from baseline to week 2, average pain intensity corresponds to average pain over the last 24 hours on the Brief Pain Inventory

Secondary outcomes

  1. Change in Brief Pain Inventory (BPI): Average pain over the last 24 hours

    Time frame: from baseline to week 6 and week 10

  2. Change in BPI: Maximal pain over the last 24 hours

    Time frame: from baseline to week 2, week 6 and week 10

  3. Change in BPI: Minimal pain over the last 24 hours

    Time frame: from baseline to week 2, week 6 and week 10

  4. Change in Neuropathic Pain Symptoms Inventory (NPSI): Burning pain

    Time frame: from baseline to week 2, week 6 and week 10

  5. Change in NPSI: Deep pain

    Time frame: from baseline to week 2, week 6 and week 10

  6. Change in NPSI: Paroxysmal pain

    Time frame: from baseline to week 2, week 6 and week 10

  7. Change in NPSI: Evoked pain

    Time frame: from baseline to week 2, week 6 and week 10

  8. Change in NPSI: Paraesthesia

    Time frame: from baseline to week 2, week 6 and week 10

  9. Change in Hamilton Depression Scale (HAMD)

    Time frame: from baseline to week 2, week 6 and week 10

  10. Change in Hamilton Anxiety Scale (HAMA)

    Time frame: from baseline to week 2, week 6 and week 10

  11. Change in Pittsburgh sleep quality index (PSQI)

    Time frame: from baseline to week 6 and week 10

  12. Change in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L): EQ-VAS

    Time frame: from baseline to week 2, week 6 and week 10

  13. Change in EQ-5D-5L: Utility score

    Time frame: from baseline to week 2, week 6 and week 10

  14. Proportion of participants with meaningful improvement compared with baseline (score as 1 or 2) in Patient Global Impression of Change (PGIC)

    Time frame: Week 2, Week 6, Week 10

    PGIC includes 7 ranks ranging from 1 to7 (1= very much improved; 2= moderately improved; 3=slightly improved; 4= no change; 5= slightly worsened; 6= moderately worsened; 7= very much worsened)

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Beijing Tiantan Hospital
  • Second Affiliated Hospital of Tsinghua University

Registry information

Official study title

Effect of Multitarget Transcranial Direct Current Stimulation (tDCS) in Patients With Neuropathic Pain

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

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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