Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer: Cross-over and Placebo-control Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

High-frequency repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) has shown its efficacy to alleviate pain in patients suffering from refractory neuropathic pain. rTMS is now considered as 3rd-line therapy (by the French Society for the Study and Treatment of Pain) for patient's refractory to drug therapy. However, its efficacy in chronic neuropathic pain related to cancer has not yet been specifically studied, and it therefore remains relatively inaccessible for these patients. This project is a cross-over, double-blinded, and placebo-control study, including 5 sessions of either M1 or sham rTMS, a wash-out period (8 weeks), followed by 5 sessions of the other stimulation option (I.e., two arms: M1-sham or sham-M1; order randomized between patients). Treatment efficacy will be assessed in comparison to the placebo condition. Primary outcome is the percentage of pain relief between active and sham rTMS. Other variables to describe quality of life, sensory, neuropathic, and mood states as well as resting-state fMRI will be collected before and after treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
PEYRON Roland
RECRUITING
Saint-etienne
Contact Information
Primary
Roland PEYRON, PhD
roland.peyron@chu-st-etienne.fr
0477824095
Time Frame
Start Date: 2025-06-13
Estimated Completion Date: 2029-05
Participants
Target number of participants: 60
Treatments
Experimental: Active rTMS - Sham
5 stimulation sessions on M1 - washout 8 weeks - 5 sham stimulation sessions (placebo-control, same site, inactive stimulation)
Experimental: Sham - Active rTMS
5 sham stimulation sessions (placebo-control, same site, inactive stimulation) - washout 8 weeks - 5 stimulation sessions on M1
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne

This content was sourced from clinicaltrials.gov