Status:
RECRUITING
Neuromodulation in Patients With Neuropathic Pain and Depression.
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Neuropathic Pain
Depression
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
High-frequency repetitive transcranial magnetic stimulation of the primary motor cortex has shown its effect on refractory neuropathic pain, and rTMS of the dorsolateral prefrontal cortex is commonly ...
Detailed Description
This project is a cross-over study for these patients, including 4 sessions of either M1 or DLPFC rTMS, a wash-out period, followed by 4 sessions of the other stimulation site, to assess the efficienc...
Eligibility Criteria
Inclusion
- Central or peripheral neuropathic pain
- Chronic pain (present for more than 6 months) with intensity greater than or equal to 4/10 on the numerical scale
- Pain present on a daily or near-daily basis (at least 4 days a week)
- Patient not completely relieved by recommended drug treatments for first- and second-line 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 with a depressive episode characterized according to DSM V criteria
- Indication for motor cortex rTMS by a neurologist
- Patient can be followed for the entire duration of the study
- Patient having received informed consent to participate in the study, and having co-signed a consent form with the investigator
- Member or beneficiary of a social security scheme
Exclusion
- Industrial accident or litigation
- Contraindication to rTMS or MRI (seismotherapy treatment since the previous month; epilepsy and/or history of epilepsy; history of head trauma; neurosurgical lesion; intracranial hypertension; intracerebral metal clip; piercing; pacemaker; insulin pump; metal prosthesis; pregnant or breast-feeding woman; claustrophobia)
- Drug or psychoactive substance abuse
- Neuropathic pain in the context of a progressive pathology (HIV, cancer, systemic disease disease)
- Presence of other pain more severe than that justifying inclusion
- Patient unable to understand informed consent
- Patient unwilling or unable to stop treatments prohibited during the study
- Patient participating in another research protocol involving a drug within the 30 days prior to inclusion
- Patient deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice safeguard, family safeguard)
- Minor patient
Key Trial Info
Start Date :
April 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06129890
Start Date
April 26 2024
End Date
March 1 2029
Last Update
July 1 2025
Active Locations (1)
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1
CHU de Saint-Etienne
Saint-Etienne, France, 42055