Effect of Multitarget tDCS for Neuropathic Pain

Not Applicable

Not yet recruiting

• Conditions: Neuropathic Pain
• Interventions: Device: Sham tDCS; Device: Single-target tDCS; Device: Mutitarget tDCS

• Registration Number: NCT06510725
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-14
• Last Update Submitted: 2024-07-14
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Study Start: 2024-08-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	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.
Single-target tDCS	Single-target tDCS	Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays.
Mutitarget tDCS	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.

Primary Outcome Measures

Name	Time	Method
Change in average pain intensity	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 Outcome Measures

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