Effect of Multitarget tDCS for Neuropathic Pain

July 14, 2024 updated by: Xuanwu Hospital, Beijing

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. Active central nervous system diseases including but not limited to brain tumour, intracranial hypertension, past or current epilepsy.
  3. Unable to complete the questionnaire due to language abilities or reduced cognitive functioning.
  4. Alcohol or substance abuse.
  5. 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.
  6. Unwilling to comply with the treatment or follow-up assessments.
  7. Participating in another clinical trial within 3 months prior to enrollment of this clinical trial.
  8. Any patient deemed unsuitable for enrollment by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mutitarget tDCS
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.
Device: Mutitarget tDCS
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.
Experimental: Single-target tDCS
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays.
Device: Single-target tDCS
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays.
Sham Comparator: Sham tDCS
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.
Device: Sham tDCS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Pain Inventory (BPI): Average pain over the last 24 hours
Time Frame: from baseline to week 6 and week 10
from baseline to week 6 and week 10
Change in BPI: Maximal pain over the last 24 hours
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
Change in BPI: Minimal pain over the last 24 hours
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
Change in Neuropathic Pain Symptoms Inventory (NPSI): Burning pain
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
Change in NPSI: Deep pain
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
Change in NPSI: Paroxysmal pain
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
Change in NPSI: Evoked pain
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
Change in NPSI: Paraesthesia
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
Change in Hamilton Depression Scale (HAMD)
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
Change in Hamilton Anxiety Scale (HAMA)
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
Change in Pittsburgh sleep quality index (PSQI)
Time Frame: from baseline to week 6 and week 10
from baseline to week 6 and week 10
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
from baseline to week 2, week 6 and week 10
Change in EQ-5D-5L: Utility score
Time Frame: from baseline to week 2, week 6 and week 10
from baseline to week 2, week 6 and week 10
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)
Week 2, Week 6, Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Collaborators

Beijing Tiantan Hospital
Second Affiliated Hospital of Tsinghua University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 14, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zhuhongwei

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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