Neuromodulation for treating neuropathic pain and depression
Neuromodulation in Patients With Neuropathic Pain and Depression: a Cross-over Study Between Two Targets in Transcranial Magnetic Stimulation, the Primary Motor Cortex and the Dorsolateral Prefrontal Cortex.
NA · Centre Hospitalier Universitaire de Saint Etienne · NCT06129890
This study is testing if a special brain treatment can help people with both nerve pain and depression feel better when regular pain medications haven't worked.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne (other) |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT06129890 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of high-frequency repetitive transcranial magnetic stimulation (rTMS) on patients suffering from both neuropathic pain and depression. It employs a cross-over design where participants will undergo four sessions of rTMS targeting either the primary motor cortex (M1) or the dorsolateral prefrontal cortex (DLPFC), followed by a wash-out period and then sessions targeting the alternate site. The study aims to assess the efficacy of DLPFC rTMS in alleviating neuropathic pain while also evaluating changes in mood, quality of life, and pain catastrophizing. The study is designed for patients who have not found relief from standard pain medications.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic neuropathic pain and a depressive episode who have not responded adequately to conventional treatments.
Not a fit: Patients with contraindications to rTMS or those involved in litigation related to industrial accidents may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from both neuropathic pain and depression.
How similar studies have performed: While studies have shown success with rTMS for either condition separately, this specific approach for concurrent neuropathic pain and depression is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint-Etienne
- CHU de Saint-Etienne — Saint-Etienne, France (RECRUITING)
Study contacts
- Study coordinator: Roland PEYRON, PhD
- Email: roland.peyron@univ-st-etienne.fr
- Phone: (0)4 77 12 78 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuropathic Pain, Depression, Neuropathic pain, Depressive Disorder, transcranial magnetic stimulation, neuromodulation, pain relief