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CORTICAL STIMULATION BY DIRECT CURRENT FOR THE TREATMENT OF CHRONIC PAIN : PILOT-STUDY OF A STIMULATION DEVICE AT HOME (STIMATHOME)

Primary Purpose

Neuropathic Pain

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

tDCS (use at home)

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring neuropathic pain, neurostimulation, ambulatory use, tDCS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with neuropathic chronic pain

Arm Description

Outcomes

Primary Outcome Measures

Quality of sleep : numerical rating scale (NRS) from 0 (no sleep) to 10 (very good sleep).

Fatigue : numerical rating scale (NRS) from 0 (exhausted) to 10 (very well)

Secondary Outcome Measures

Full Information

NCT ID

NCT02346396

First Posted

January 7, 2015

Last Updated

April 27, 2021

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT02346396

Brief Title

CORTICAL STIMULATION BY DIRECT CURRENT FOR THE TREATMENT OF CHRONIC PAIN : PILOT-STUDY OF A STIMULATION DEVICE AT HOME

Acronym

STIMATHOME

Official Title

Non-invasive Analgesic Stimulation of the Motor Cortex at Home

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 9, 2015 (Actual)

Primary Completion Date

November 9, 2023 (Anticipated)

Study Completion Date

November 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain

Keywords

neuropathic pain, neurostimulation, ambulatory use, tDCS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with neuropathic chronic pain

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

tDCS (use at home)

Intervention Description

During 4 weeks (every week : 20 minutes / day during 5 days)

Primary Outcome Measure Information:

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luis Garcia-Larrea, Doctor

Phone

4 72 35 78 88

Ext

+33

larrea@univ-lyon1.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Nathalie André-Obadia, Doctor

Phone

4 72 35 70 68

Ext

+33

nathalie.obadia-andre@chu-lyon.fr

Facility Information:

Facility Name

Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD)

City

Bron

ZIP/Postal Code

69500

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis Garcia-Larrea, Doctor

Phone

4 72 35 78 88

Ext

+33

larrea@univ-lyon1.fr

First Name & Middle Initial & Last Name & Degree

Nathalie André-Obadia, Doctor

Phone

4 72 35 70 68

Ext

+33

nathalie.obadia-andre@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Luis Garcia-Larrea, Doctor

First Name & Middle Initial & Last Name & Degree

Nathalie André-Obadia, Doctor

First Name & Middle Initial & Last Name & Degree

Patrick Mertens

12. IPD Sharing Statement

Learn more about this trial

CORTICAL STIMULATION BY DIRECT CURRENT FOR THE TREATMENT OF CHRONIC PAIN : PILOT-STUDY OF A STIMULATION DEVICE AT HOME

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