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

December 22, 2023 updated by: Hospices Civils de Lyon

Non-invasive Analgesic Stimulation of the Motor Cortex at Home

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Garcia-Larrea, Doctor
        • Sub-Investigator:
          • Nathalie André-Obadia, Doctor
        • Principal Investigator:
          • Patrick MERTENS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with neuropathic chronic pain
Device: tDCS (use at home)
During 4 weeks (every week : 20 minutes / day during 5 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of sleep : numerical rating scale (NRS) from 0 (no sleep) to 10 (very good sleep).
Time Frame: 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)
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)
Fatigue : numerical rating scale (NRS) from 0 (exhausted) to 10 (very well)
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2015

Primary Completion (Estimated)

May 9, 2027

Study Completion (Estimated)

May 9, 2027

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimated)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

January 2, 2024

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.869
  • 2014-A01437-40 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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