Last updated: April 29, 2024
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pain (Pediatric)
Neuropathy
Oral Facial Pain
Treatment
Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC
Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1
Clinical Study ID
NCT06129890
23CH155
ANSM
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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- andsecond-line neuropathic pain
- Stable analgesic treatment (no new treatment or dosage adjustment) for at least onemonth, 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 havingco-signed a consent form with the investigator
- Member or beneficiary of a social security scheme
Exclusion
Exclusion Criteria:
- 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; insulinpump; metal prosthesis; pregnant or breast-feeding woman; claustrophobia)
- Drug or psychoactive substance abuse
- Neuropathic pain in the context of a progressive pathology (HIV, cancer, systemicdisease 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 daysprior to inclusion
- Patient deprived of liberty or under legal protection (guardianship, curatorship,safeguard of justice safeguard, family safeguard)
- Minor patient
Study Design
Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC
Phase:
Study Start date:
April 26, 2024
Estimated Completion Date:
March 31, 2029
Study Description
Connect with a study center
CHU de Saint-Etienne
Saint-Étienne, 42055
FranceActive - Recruiting
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