Effect of Multitarget tDCS for Neuropathic Pain

NCT ID: NCT06510725

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Mutitarget tDCS

Intervention Type 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

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

Group Type EXPERIMENTAL

Single-target tDCS

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Single-target tDCS

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Tsinghua University

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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zhuhongwei

Identifier Type: -

Identifier Source: org_study_id

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