rTMS over the motor cortex for cancer-related neuropathic pain
Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer: Cross-over and Placebo-control Study
This trial will try high-frequency rTMS over the primary motor cortex to relieve chronic neuropathic pain in adults with cancer who have not responded to standard drug treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT07187219 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled crossover trial comparing five sessions of active high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex (M1) with five sessions of sham stimulation. Participants receive one treatment block, then an eight-week washout, followed by the alternate block, with order randomized. The primary outcome is the percentage difference in pain relief between active and sham rTMS; additional measures will capture quality of life and other pain-related variables. Eligible patients are adults with chronic (≥4 months) cancer-related central or peripheral neuropathic pain refractory to first- and second-line drugs and on a stable analgesic regimen.
Who should consider this trial
Good fit: Adults aged 18–85 with chronic (≥4 months) central or peripheral neuropathic pain related to cancer or its treatment, pain intensity ≥4/10, inadequate relief from recommended first- and second-line drugs, stable analgesic treatment, and an rTMS indication by a neurologist are ideal candidates.
Not a fit: Patients with non-neuropathic pain, pain under 4/10, unstable or recently changed analgesic regimens, or inability to attend in-person sessions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could provide meaningful pain relief and improve quality of life for patients with cancer-related neuropathic pain without requiring medication changes.
How similar studies have performed: High-frequency rTMS over M1 has shown pain relief in prior trials of refractory neuropathic pain and is recommended as a third-line option in some guidelines, but its effectiveness specifically for cancer-related neuropathic pain has not been well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient affiliated to or entitled under a social security scheme * Patient who has received informed information about the study and who has co-signed, with the investigator, a consent form to participate in the study. * Patient aged 18 to 85 (male or female), * Central or peripheral neuropathic pain related to cancer and/or its treatment; * Chronic pain (present for more than 4 months) whose intensity is greater than or equal to 4/10 on a VAS (Visual Analogue Scale) numerical scale. * Pain present on a daily or almost daily basis (at least 4 days a week) * Patient not completely relieved by recommended first- and second-line drug treatments for neuropathic pain * Stable analgesic treatment (no new treatment or dosage adjustment) for at least one month and will not need to be modified for the duration of the study. * Patient can be followed throughout the study. * Indication for rTMS of the motor cortex by a neurologist. Exclusion Criteria: * Accident at work or litigation, * Contraindication to rTMS or MRI (treatment with seismotherapy during the previous month; history of cranial trauma; intracranial hypertension; intracerebral metal clip; piercing; pacemaker; insulin pump; metal prosthesis; pregnant or breast-feeding woman; claustrophobia). * Chronic alcoholism * Abuse of drugs or psychoactive substances * Neuropathic pain as part of a progressive pathology (e.g. HIV), * Presence of other pain of greater intensity than the neuropathic pain leading to inclusion * Acute stroke (\< 3 months) * Patient with brain tumour lesions * Patient with infectious or metabolic brain lesions * Patients with severe or recent cardiac disorders * Patients with cognitive impairment * Patient unable to understand informed consent, * Patients refusing to stop or unable to stop treatments prohibited during the study, such as morphine. * Patients participating in another research protocol involving a medicinal product within 30 days prior to inclusion. * Patients deprived of their liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation).
Where this trial is running
Saint-Etienne
- PEYRON Roland — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Roland PEYRON, PhD — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Roland PEYRON, PhD
- Email: roland.peyron@chu-st-etienne.fr
- Phone: 0477824095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.