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

Not Applicable

Recruiting

• Conditions: Cancer; Chronic Neuropathic Pain

• Registration Number: NCT07187219
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-13
• Study First Submitted: 2025-06-18
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2028-11
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
PAIN RELIEF	Week 7 after the start of RTMs stimulation	PAIN from 0% : no pain relief at all to 100%: completely relief.

Secondary Outcome Measures

Name	Time	Method
Pain relief	day 7 post RTMs stimulation	scale ranging from 0% = no relief to 100% = fully relieved
Visual Analogic Scale VAS on emotional dimension of pain	day 7 post RTMs stimulation	Visual Analogic Scale VAS (0 = not unpleasant) to 10 = extremely unpleasant)
Visual Analogic Scale (VAS) on attentional dimension of pain	day 7 post RTMs stimulation	0 = does not attract at all to 10 = completely attracts
consumption of rescue analgesics	Week 7 after the start of RTMs stimlulation
Effect of rTMS on quality of life	Week 7 after the start of RTMs stimlulation	Quality of life score (EQ-5D) from 0 to 100. 100 corresponds to the best health.
HADS: Hospital Anxiety and Depression Scale	Week 7 after the start of RTMs stimlulation	from 0 to 14: no anxiety disorders; from 15 to 42: existence of anxiety disorders.
Pain Intensity with Visual analog scale (VAS)	day 7 post RTMs stimulation	0 no pain to 10 extremely pain
score of Neuropathic Pain Symptom Inventory - NPSI	day 7 post RTMs stimulation	\[0= zero neuropatthic pain to 100= maximum neuropathic pain\]
Brief Pain Inventory - BPI	day 7 post RTMs stimulation	1 - 4 = Mild Pain. 5 =Worst Pain Score 6 = Moderate Pain. 7=Worst Pain Score 10 = Severe Pain.
Tolerance	week 7 after the start of RTMs stimulation	Tolerance will be defined as the absence of adverse effects throughout the duration of the protocol, as reported in systematic questionnaires."

Trial Locations

Locations (1)

PEYRON Roland; 🇫🇷 Saint-Etienne, France