Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer

NCT ID: NCT07187219

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-13
• Study Completion Date: 2029-05-31

Brief 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.

Conditions

Cancer; Chronic Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active rTMS - Sham

5 stimulation sessions on M1 - washout 8 weeks - 5 sham stimulation sessions (placebo-control, same site, inactive stimulation)

Group Type: EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS) - active

Intervention Type: DEVICE

rTMS session active on the primary motor cortex

Repetitive transcranial magnetic stimulation (rTMS) - inactive

Intervention Type: DEVICE

rTMS session inactive on the primary motor cortex

Sham - Active rTMS

5 sham stimulation sessions (placebo-control, same site, inactive stimulation) - washout 8 weeks - 5 stimulation sessions on M1

Group Type: EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS) - active

Intervention Type: DEVICE

rTMS session active on the primary motor cortex

Repetitive transcranial magnetic stimulation (rTMS) - inactive

Intervention Type: DEVICE

rTMS session inactive on the primary motor cortex

Interventions

Repetitive transcranial magnetic stimulation (rTMS) - active

rTMS session active on the primary motor cortex

Intervention Type: DEVICE

Repetitive transcranial magnetic stimulation (rTMS) - inactive

rTMS session inactive on the primary motor cortex

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland PEYRON, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

PEYRON Roland

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Roland PEYRON, PhD

Role: CONTACT

roland.peyron@chu-st-etienne.fr

0477824095 ext. 33

Facility Contacts

Roland PEYRON, PhD

Role: primary

roland.peyron@chu-st-etienne.fr

0477824095 ext. 33

Other Identifiers

2024-A01195-42

Identifier Type: OTHER

Identifier Source: secondary_id

24CH024

Identifier Type: -

Identifier Source: org_study_id