Neuromodulation in Patients With Neuropathic Pain and Depression. (DOLODEP)

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Neuropathic Pain; Depression

Treatments: Device: Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC; Device: Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1

Study type: Interventional

Funder types: Other

Identifiers

NCT06129890

ANSM (Other Identifier)

23CH155

Details and patient eligibility

About

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 used for treatment-resistant depression.

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.

Full 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 efficiency of a DLPFC rTMS for neuropathic pain with a comorbid depression. Besides pain intensity and quality, patient's mood, quality of life, and catastrophizing will be assessed.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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- 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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

M1 - DLPFC

Other group

Description:

Initial primary motor cortex stimulation (M1) followed by cortex prefrontal cortex (DLPFC) : rTMS of M1, washout, rTMS of DLPFC

Treatment:

Device: Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC

DLPFC - M1

Other group

Description:

Initial cortex prefrontal cortex (DLPFC) stimulation followed by primary motor cortex stimulation (M1) : rTMS of DLPFC, washout, rTMS of M1

Treatment:

Device: Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1