Effect of Multitarget tDCS for Neuropathic Pain

NCT06510725 | Not Yet Recruiting DMC

• 1 other identifier: zhuhongwei
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change in average pain intensity

  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 Outcomes (14)

• 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 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: Deep pain

  from baseline to week 2, week 6 and week 10

Study Arms (3)

Mutitarget tDCS

EXPERIMENTAL

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

Single-target tDCS

EXPERIMENTAL

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

Device: Single-target tDCS

Sham tDCS

SHAM COMPARATOR

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

Interventions

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.

Mutitarget tDCS

Single-target tDCS DEVICE

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

Single-target tDCS

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.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Beijing Tiantan Hospital: collaborator
• Second Affiliated Hospital of Tsinghua University: collaborator

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 19, 2024
• Study Start: August 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share