Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive transcranial magnetic stimulation (rTMS) - active, Repetitive transcranial magnetic stimulation (rTMS) - inactive.
- Who it may be relevant to
- Registry conditions: Cancer, Chronic Neuropathic Pain. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Repetitive Transcranial Magnetic Stimulation Over the Primary Cortex in Patients With Neuropathic Pain and Cancer: Cross-over and Placebo-control Study
Overview
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.
Interventions
- Device Repetitive transcranial magnetic stimulation (rTMS) - active
rTMS session active on the primary motor cortex - Device Repetitive transcranial magnetic stimulation (rTMS) - inactive
rTMS session inactive on the primary motor cortex
Primary outcome measures
- PAIN RELIEF [Time frame: Week 7 after the start of RTMs stimulation]
Secondary outcome measures (10)
- Pain Intensity with Visual analog scale (VAS) [Time frame: day 7 post RTMs stimulation]
- score of Neuropathic Pain Symptom Inventory - NPSI [Time frame: day 7 post RTMs stimulation]
- Brief Pain Inventory - BPI [Time frame: day 7 post RTMs stimulation]
- Pain relief [Time frame: day 7 post RTMs stimulation]
- Visual Analogic Scale VAS on emotional dimension of pain [Time frame: day 7 post RTMs stimulation]
- Visual Analogic Scale (VAS) on attentional dimension of pain [Time frame: day 7 post RTMs stimulation]
- consumption of rescue analgesics [Time frame: Week 7 after the start of RTMs stimlulation]
- Effect of rTMS on quality of life [Time frame: Week 7 after the start of RTMs stimlulation]
- HADS: Hospital Anxiety and Depression Scale [Time frame: Week 7 after the start of RTMs stimlulation]
- Tolerance [Time frame: week 7 after the start of RTMs stimulation]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- PEYRON Roland — Saint-Etienne
Identifiers
NCT: NCT07187219 · 24CH024 · 2024-A01195-42