Actively Recruiting
Classical, Spaced, or Accelerated Transcranial Magnetic Stimulation of Motor Cortex for Treating Neuropathic Pain: a 3-arm Parallel Non-inferiority Study
Led by Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy) · Updated on 2025-05-09
36
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating three different repetitive transcranial magnetic stimulation (rTMS) protocols to treat chronic neuropathic pain, a condition where drugs only relieve symptoms in about half of patients. This study compares the classical high-frequency rTMS (CHF-rTMS), spaced high-frequency rTMS (SHF-rTMS), and accelerated intermittent theta burst stimulation (ACC-iTBS), which has not been previously tested for chronic pain. The goal is to understand how the number of pulses and sessions influences pain relief and to find a protocol that balances effectiveness and ease of use. The study randomly assigns 36 patients aged 18 to 80 with painful peripheral neuropathy to one of the three rTMS groups. All treatments target the primary motor cortex contralateral to pain at 80% of resting motor threshold using a figure-of-eight coil. CHF-rTMS delivers 3,000 pulses per session over 10 sessions in 7 weeks. SHF-rTMS delivers 1,600 pulses per session over 4 weekly sessions totaling 6,400 pulses. ACC-iTBS involves 20 sessions over 4 days with 1,500 pulses per session totaling 30,000 pulses. The sessions differ in frequency, duration, and intervals. Participants attend multiple visits including screening, inclusion, two full assessment visits with clinical questionnaires and neurophysiological tests (EEG, TMS-EEG evoked potentials, and paired-pulse TMS), and a final visit. They keep a pain diary and undergo weekly follow-ups for 11 weeks to monitor pain intensity, impact, side effects, and global impression of change. The main outcome measured is the interference of pain with daily activities, assessed up to 5 weeks after treatment completion.
CONDITIONS
Brief Title
Protocol Assessment of Motor Cortex rTMS for Treating Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Definite peripheral neuropathy confirmed clinically and neurophysiologically for at least 6 months
- Neuropathic pain related to neuropathy with a DN4 score of 4 or higher
- Average daily pain intensity of 4 or higher on a 0-10 numerical rating scale
- Age between 18 and 80 years
- Affiliation with the social security system
- Ability to provide signed informed consent
You will not qualify if you...
- Presence of neurological or psychiatric illnesses such as neurodegenerative disorders, migraine, epilepsy, stroke, or tumors
- Contraindications to transcranial magnetic stimulation such as intracranial ferromagnetic material
- Drug-resistant or active epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 3 weeks
Participants undergo detailed clinical and neurophysiological assessments including pain diaries, questionnaires, resting-state EEG, TMS-EEG evoked potentials, and threshold-tracking of intracortical inhibition.
2 visits (in-person)
Duration - 4 to 7 weeks depending on treatment arm
Participants receive one of three transcranial magnetic stimulation (TMS) protocols targeting the motor cortex to treat neuropathic pain. Treatment schedules vary by group involving daily or weekly sessions over several weeks.
Multiple in-person sessions: up to 5 daily sessions per day for 2 days in some groups; weekly sessions in others
Duration - 11 weeks
Participants are monitored weekly for 11 weeks after starting treatment with clinical evaluations including pain diaries, questionnaires, and collection of any side effects. Two comprehensive assessment visits include neurophysiological testing.
Weekly visits with 2 complete assessment visits and a final visit (all in-person), plus phone calls during follow-up
Trial Site Locations
Total: 1 location
1
Henri Mondor University Hospital
Créteil, Île-de-France Region, France, 94000
Actively Recruiting
Research Team
J
Jean-Pascal Lefaucheur, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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