Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer
NeuroCanPain
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Jun 2025
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2025
CompletedFirst Submitted
Initial submission to the registry
June 18, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
September 22, 2025
September 1, 2025
3.4 years
June 18, 2025
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PAIN RELIEF
PAIN from 0% : no pain relief at all to 100%: completely relief.
Week 7 after the start of RTMs stimulation
Secondary Outcomes (10)
Pain Intensity with Visual analog scale (VAS)
day 7 post RTMs stimulation
score of Neuropathic Pain Symptom Inventory - NPSI
day 7 post RTMs stimulation
Brief Pain Inventory - BPI
day 7 post RTMs stimulation
Pain relief
day 7 post RTMs stimulation
Visual Analogic Scale VAS on emotional dimension of pain
day 7 post RTMs stimulation
- +5 more secondary outcomes
Study Arms (2)
Active rTMS - Sham
EXPERIMENTAL5 stimulation sessions on M1 - washout 8 weeks - 5 sham stimulation sessions (placebo-control, same site, inactive stimulation)
Sham - Active rTMS
EXPERIMENTAL5 sham stimulation sessions (placebo-control, same site, inactive stimulation) - washout 8 weeks - 5 stimulation sessions on M1
Interventions
rTMS session active on the primary motor cortex
rTMS session inactive on the primary motor cortex
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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),
- 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 deprived of their liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PEYRON Roland
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland PEYRON, PhD
CHU SAINT-ETIENNE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2025
First Posted
September 22, 2025
Study Start
June 13, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
May 1, 2029
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share