Actively Recruiting
Efficacy of Home-delivered Transcranial Direct Electrical Stimulation or Chronic Pain
Led by Hospital Ambroise Paré Paris · Updated on 2025-10-07
70
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Home-delivered Transcranial Direct Electrical Stimulation or Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic pain lasting at least 6 months
- Pain intensity of 4 or more on a 0-10 numeric rating scale
- Pain present every day or nearly every day
- Neuropathic pain (DN4 score 4 or higher) or nociplastic pain
- Previous treatment with motor cortex rTMS resulting in at least 30% pain relief lasting less than one month
- Affiliated with social security
You will not qualify if you...
- Contraindications to tDCS such as implantable devices, severe cognitive disorders, epilepsy, skin problems at electrode sites, thrombosis, thrombophlebitis, metallic intracranial implants, craniotomy, intracranial aneurysm, cerebral tumor, or severe sleep disorders like narcolepsy
- Use of treatments that increase epilepsy risk (high doses of opioids or tricyclic antidepressants)
- Pregnancy or lactation
- Age below 18 or above 80 years
- Pending litigation related to pain
- Pain more severe than neuropathic or nociplastic pain requiring treatment
- Severe diseases like cancer
- Severe psychiatric conditions such as psychosis
- Inability to be followed for 3 months
- Participation in another clinical trial within the last 3 months
- Psychoactive drug abuse
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre d'Evaluation et de Traitement de la douleur, INSERM U 987
Boulogne-Billancourt, Hauts de Seine, France, 92100
Actively Recruiting
Research Team
N
Nadine ATTAL, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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