NCT07211256 Efficacy of Home-delivered Transcranial Direct Electrical Stimulation or Chronic Pain
| NCT ID | NCT07211256 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Ambroise Paré Paris |
| Condition | Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-01-09 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-01-09 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Contact & Investigator
Nadine ATTAL, MD PhD
STUDY DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Frequently Asked Questions
Who can join the NCT07211256 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07211256 currently recruiting?
Yes, NCT07211256 is actively recruiting participants. Contact the research team at nadine.attal@aphp.fr for enrollment information.
Where is the NCT07211256 trial being conducted?
This trial is being conducted at Boulogne-Billancourt, France.
Who is sponsoring the NCT07211256 clinical trial?
NCT07211256 is sponsored by Hospital Ambroise Paré Paris. The principal investigator is Nadine ATTAL, MD PhD at Institut National de la Santé Et de la Recherche Médicale, France. The trial plans to enroll 70 participants.