rTMS over the motor cortex for cancer-related neuropathic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.