Neuromodulation in Patients With Neuropathic Pain and Depression.

NCT ID: NCT06129890

Last Updated: 2025-07-01

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neuropathic Pain Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Group Type OTHER

Repetitive transcranial magnetic stimulation (rTMS) - M1/DLPFC

Intervention Type DEVICE

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

Group Type OTHER

Repetitive transcranial magnetic stimulation (rTMS) - DLPFC/M1

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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rTMS rTMS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Roland PEYRON, PhD

Role: CONTACT

(0)4 77 12 78 05 ext. +33

Hélène RAINGARD, CRA

Role: CONTACT

Facility Contacts

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Roland PEYRON, PhD

Role: primary

(0)4 77 12 78 05 ext. +33

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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