Actively Recruiting
Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer: Cross-over and Placebo-control Study
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-09-22
60
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of high-frequency repetitive transcranial magnetic stimulation (rTMS) on the primary motor cortex (M1) to reduce chronic neuropathic pain related to cancer. While rTMS is recognized as a third-line treatment for refractory neuropathic pain, its effects specifically in cancer-related neuropathic pain have not been thoroughly studied. This trial aims to compare active rTMS to a sham (inactive) control to assess pain relief and other quality of life factors. Participants will undergo a cross-over study design with two main periods: five sessions of active rTMS on the primary motor cortex followed by an eight-week washout, then five sessions of sham stimulation, or vice versa. The order of treatments is randomized. Both active and sham stimulations target the same brain site, with the sham serving as a placebo control. This design helps evaluate the effectiveness of rTMS in reducing pain compared to placebo. Throughout the study, participants will be assessed for pain relief, pain intensity, neuropathic symptoms, mood, quality of life, and brain activity using resting-state fMRI before and after treatments. These evaluations include standardized scales such as the Visual Analog Scale (VAS) for pain, Neuropathic Pain Symptom Inventory, Brief Pain Inventory, and Hospital Anxiety and Depression Scale. Safety and tolerance will also be monitored. Participant involvement spans from initial treatment sessions through follow-up assessments up to seven weeks after starting stimulation.
CONDITIONS
Brief Title
Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient affiliated to or entitled under a social security scheme
- Patient who has received informed information about the study and who has co-signed a consent form
- Patient aged 18 to 85 years, male or female
- Central or peripheral neuropathic pain related to cancer and/or its treatment
- Chronic pain lasting more than 4 months with intensity of at least 4/10 on a Visual Analogue Scale
- Pain present daily or almost daily (at least 4 days a week)
- Pain not completely relieved by recommended first- and second-line drug treatments
- Stable analgesic treatment for at least one month with no planned changes during the study
- Patient can be followed throughout the study
- Indication for rTMS of the motor cortex by a neurologist
You will not qualify if you...
- Accident at work or involved in litigation
- Contraindication to rTMS or MRI (including recent seismotherapy, cranial trauma, intracranial hypertension, metal implants, pacemaker, insulin pump, metal prosthesis, claustrophobia, pregnancy, or breastfeeding)
- Chronic alcoholism
- Abuse of drugs or psychoactive substances
- Neuropathic pain caused by progressive diseases such as HIV
- Presence of other pain more intense than neuropathic pain
- Acute stroke within the last 3 months
- Brain tumor lesions
- Infectious or metabolic brain lesions
- Severe or recent cardiac disorders
- Cognitive impairment
- Unable to understand informed consent
- Refusal or inability to stop prohibited treatments such as morphine
- Participation in another medicinal product trial within 30 days prior
- Deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 15 weeks including both treatment periods and washout
Participants receive 5 sessions of repetitive transcranial magnetic stimulation (rTMS) or sham stimulation over the primary motor cortex, followed by an 8-week washout period, then crossover to the alternate intervention with 5 additional sessions.
5 visits per treatment period plus additional visits during washout
Trial Site Locations
Total: 1 location
1
PEYRON Roland
Saint-Etienne, France, 42055
Actively Recruiting
Research Team
R
Roland PEYRON, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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