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Recruiting NCT02346396

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

No phase Interventional Neuropathic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tDCS (use at home).
Who it may be relevant to
Registry conditions: Neuropathic Pain. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Non-invasive Analgesic Stimulation of the Motor Cortex at Home

Overview

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.

Interventions

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

Primary outcome measures

  • 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)]
  • 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD) — Bron

Identifiers

NCT: NCT02346396 · 2014.869 · 2014-A01437-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗