Neuromodulation in Patients With Neuropathic Pain and Depression.
NCT ID: NCT06129890
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-04-26
2029-03-31
Brief Summary
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The treatment for patients suffering from neuropathic pain and depression, concomitantly, still needs to be studied, as there are some specificities in both symptoms and brain functional MRI.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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M1 - DLPFC
Initial primary motor cortex stimulation (M1) followed by cortex prefrontal cortex (DLPFC) :
rTMS of M1, washout, rTMS of DLPFC
Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC
Repetitive transcranial magnetic stimulation (rTMS) is a treatment technique involving the induction of an electrical current on the surface of the cortex by applying a magnetic field to the scalp. This field is generated using a stimulation loop controlled by a robotic arm linked to a neuronavigation system. rTMS of M1 then rTMS of DLPFC.
DLPFC - M1
Initial cortex prefrontal cortex (DLPFC) stimulation followed by primary motor cortex stimulation (M1) :
rTMS of DLPFC, washout, rTMS of M1
Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1
Repetitive transcranial magnetic stimulation (rTMS) is a treatment technique involving the induction of an electrical current on the surface of the cortex by applying a magnetic field to the scalp. This field is generated using a stimulation loop controlled by a robotic arm linked to a neuronavigation system. rTMS of DLPFC then rTMS of M1.
Interventions
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Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC
Repetitive transcranial magnetic stimulation (rTMS) is a treatment technique involving the induction of an electrical current on the surface of the cortex by applying a magnetic field to the scalp. This field is generated using a stimulation loop controlled by a robotic arm linked to a neuronavigation system. rTMS of M1 then rTMS of DLPFC.
Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1
Repetitive transcranial magnetic stimulation (rTMS) is a treatment technique involving the induction of an electrical current on the surface of the cortex by applying a magnetic field to the scalp. This field is generated using a stimulation loop controlled by a robotic arm linked to a neuronavigation system. rTMS of DLPFC then rTMS of M1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Locations
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CHU de Saint-Etienne
Saint-Etienne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANSM
Identifier Type: OTHER
Identifier Source: secondary_id
23CH155
Identifier Type: -
Identifier Source: org_study_id
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