Neuromodulation in Patients With Neuropathic Pain and Depression.

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

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.

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

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.

Connect with a study center

  • CHU de Saint-Etienne

    Saint-Étienne, 42055
    France

    Active - Recruiting

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