Cortical Stimulation by Direct Current for the Treatment of Chronic Pain : Pilot-study of a Stimulation Device at Home

Neuropathic Pain Clinical Trial

— STIMATHOME  

Official title:

Non-invasive Analgesic Stimulation of the Motor Cortex at Home

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02346396
• Other study ID #: 2014.869
• Secondary ID: 2014-A01437-40
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2015
• Est. completion date: May 9, 2027

Study information

• Verified date: December 2023
• Source: Hospices Civils de Lyon
• Contact: Luis Garcia-Larrea, Doctor
• Phone: 4 72 35 78 88
• Email: larrea[@]univ-lyon1.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic pain, to estimate the importance and the duration of this effect, and to improve its efficiency by the use at home. It is established that the repetition of the sessions of cortical stimulation over a week improves their analgesic efficacy. However, this effect does not exceed a few weeks and is much lower than that of the stimulation implanted surgically. Implanted stimulation operates periodically, several times a day, and this "repetition of doses ", akin to the regular taking of a medicine, may explain its longer efficacy for pain relief which, may extend over several years (André-Obadia and al 2014). No study at this date has estimated the long-term effect of non-invasive stimulation when is also periodically repeated on a daily basis, over several weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 9, 2027
• Est. primary completion date: May 9, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Device:
• tDCS (use at home)
During 4 weeks (every week : 20 minutes / day during 5 days)

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD)	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of sleep : numerical rating scale (NRS) from 0 (no sleep) to 10 (very good sleep).		over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)
Primary	Fatigue : numerical rating scale (NRS) from 0 (exhausted) to 10 (very well)		over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)