Efficacy of Home-delivered Transcranial Direct Electrical Stimulation or Chronic Pain

NCT07211256 | Recruiting

• 1 other identifier: 2023-A02797-38
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical investigation aims to evaluate the efficacy and safety of a home-based device providing electrical stimulation of the brain named transcranial direct current stimulation (tDCS ) , in patients with chronic pain who have been transiently relieved by repetitive transcranial magnetic stimulation delivered at hospital (less than one month benefit). The general objective is to show that these patients may best benefit from home based tDCS while rTMS performed in hospital has only limited and transient efficacy. Each participant will be randomized into one of two arms to receive during 3 months either active tDCS or sham tDCS. Neither the investigator nor the patient will be aware of the treatment. The efficacy will be assessed on pain intensity (primary outcome at 3 months) and several secondary outcomes (qualify of life, pain symptoms , global impression of change, pain relief, sleep, anxiety, depression) every month for up to 3 months. Safety will be assessed at each follow up visit for up to 3 months. The participants will be asked to self stimulate themselves with the device 5 days per week for about 20 minutes.

Conditions

Neuropathic Pain; Nociplastic Pain

Keywords

randomized; neuropathic pain; nociplastic pain; placebo controlled; tDCS; home-delivered

Outcome Measures

Primary Outcomes (1)

• Self reported pain intensity in a diary

  Weekly average of the last 7 numerical pain scores (from 0 no pain to 10 maximal pain imaginable) recorded every day by the patient at the end of the treatment as compared to baseline values

  Baseline and 12 weeks

Secondary Outcomes (21)

• Effects on self reported pain intensity over the course of the study

  over the course of the study from baseline to week 12

• EQ-5D-5L (EuroQol)

  Baseline, then week 1 (± 3 days), week 4, week 8 and week 12

• Brief Pain Inventory

  Baseline, then week 1 (± 3 days), week 4, week 8 and week 12

• Neuropathic Pain Symptom Inventory (NPSI)

  Baseline, then week 1, week 4, week 8 and week 12 after the treatment

• Fibromyalgia Impact Questionnaire (FIQ)

  Baseline, then week 1 (± 3 days), week 4, week 8 and week 12

Other Outcomes (3)

• Predictors of the response to tDCS

  Baseline

• Easyness of use

  Days 3-5, then week 1, then weeks 4, 8 and 12 after the treatment

• Predictor of the response to placebo

  Baseline

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Active tDCS of the motor cortex

Device: tDCS of the motor cortex

Sham tDCS

SHAM COMPARATOR

Sham tDCS of the motor cortex

Device: tDCS of the motor cortex

Interventions

tDCS of the motor cortex DEVICE

Home-delivered tDCS device

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic pain for at least 6 months Pain intensity ≥ 4/10 on 0-10 NRS Pain present every day or nearly every day Neuropathic pain (DN4 score ≥ 4/10) or nociplastic pain (Kosek et al Pain 2021) Patients previously treated with rTMS of the motor cortex in routine in our pain center but with only transient efficacy (ie, efficacy for less than one month, defined as pain intensity improved by at least 30 %) Affilitated to social security

You may not qualify if:

• Contraindications to tDCS as stated in the manufacturer brochure (ie, implantable device , severe cognitive disorders, epilepsia, skin problems where will placed the electrodes, arterial or venous thrombosis, thrombophlebitis, metallic intracranial implant, cranioth-omy, incracranial aneuvrysm, cerebral tumor, severel sleep disorders such as narcolepsia) Conciomitant treatment which might increase the risk of epilepsia such as high doses opioids (≥ 140 mg morphine equivalent) or high. doses tricyclic antidepressants (≥ 150 mg per day) Pregnancy or lactation Age below 18 or \> 80 years Pending litigation related to pain Pain more severe than neuropathic or nociplastic pain requiring treatment Severe disease such as cancer Severe psychiatric condition (psychosis) Impossible to be followed for up to 3 months Participation in a recent protocol (less than 3 months) Psychoactive drug abuse

Sponsors & Collaborators

• Hospital Ambroise Paré Paris: lead

Study Sites (1)

Centre d'Evaluation et de Traitement de la douleur, INSERM U 987

Boulogne-Billancourt, Hauts de Seine, 92100, France

RECRUITING

MeSH Terms

Conditions

Neuralgia; Nociplastic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Nadine ATTAL, MD PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Central Study Contacts

Nadine ATTAL, MD PhD

CONTACT

0033149095931; nadine.attal@aphp.fr

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: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: October 7, 2025
• Study Start: January 9, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)