Study Results
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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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2024-08-01
2026-01-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
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.
Single-target tDCS
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays.
Single-target tDCS
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.
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.
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.
Single-target tDCS
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Second Affiliated Hospital of Tsinghua University
OTHER
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Other Identifiers
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zhuhongwei
Identifier Type: -
Identifier Source: org_study_id
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