Home-based cortical stimulation for chronic neuropathic pain relief
Non-invasive Analgesic Stimulation of the Motor Cortex at Home
This study is testing whether a home-based brain stimulation treatment can help people with chronic nerve pain who haven't found relief from regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Trial ID | NCT02346396 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in alleviating chronic neuropathic pain in patients who have not responded to conventional medications. The study will assess the analgesic effects of tDCS when administered at home, focusing on the importance and duration of pain relief achieved through repeated sessions over several weeks. By utilizing a non-invasive approach, the study seeks to improve the efficiency of pain management for individuals suffering from long-term neuropathic pain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with pharmacoresistant neuropathic chronic pain lasting over one year.
Not a fit: Patients with a history of drug addiction, epilepsy, or those with intracranial ferromas may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective, and non-invasive treatment option for patients with chronic neuropathic pain.
How similar studies have performed: While this approach is relatively novel, previous studies have shown promise in using tDCS for pain management, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria :
* Patients from 18 to 80 years old, men or women, suffering pharmaco-resistant neuropathic chronic pain for more than one year; NVS \> 2 during the week S0) unilateral pharmacoresistant, whose analgesic treatment is stable for at least 1 month.
* Patients whose pharmacoresistance leads their referent doctor to consider non-pharmacological therapeutic alternatives and begin a presurgical assessment.
* Patients having an operational Internet connection. The patient or one person of its circle of acquaintances will have to be able to connect on the Internet and to reach by this way the system of relocated stimulation ("The Cloud").
* Patients having shown pain relief to a single- or whole-week sessions of tDCS are not excluded from potential recruitment for this study.
* Patients having a social security cover.
* Patients having given their written consent.
Exclusion Criteria :
* History
* of addiction to drugs,
* of epilepsy.
* Présence of an intra-cranial ferromagnetic equipment or of an implanted stimulation device (e.g. stimulating, central grey pacemaker, stimulation of the basal ganglia or of the vagus nerve).
* Introduction of a new analgesic treatment for less than a month.
* Lack of a effective contraception for all the duration of the study for the patients old enough to procreate.
(No limitation in the inclusion of male patients old enough to procreate).
* Patient under legal protective measure.
* Pregnant women and nursing mothers
Where this trial is running
Bron
- Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD) — Bron, France (Recruiting)
Study contacts
- Study coordinator: Luis Garcia-Larrea, Doctor
- Email: larrea@univ-lyon1.fr
- Phone: 4 72 35 78 88
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.