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

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ClinicalTrials.gov Identifier: NCT02346396
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE January 7, 2015
First Posted Date  ICMJE January 27, 2015
Last Update Posted Date April 28, 2021
Actual Study Start Date  ICMJE February 9, 2015
Estimated Primary Completion Date November 9, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2015)
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CORTICAL STIMULATION BY DIRECT CURRENT FOR THE TREATMENT OF CHRONIC PAIN : PILOT-STUDY OF A STIMULATION DEVICE AT HOME
Official Title  ICMJE Non-invasive Analgesic Stimulation of the Motor Cortex at Home
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE Device: tDCS (use at home)
During 4 weeks (every week : 20 minutes / day during 5 days)
Study Arms  ICMJE Experimental: Patients with neuropathic chronic pain
Intervention: Device: tDCS (use at home)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2015)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 9, 2023
Estimated Primary Completion Date November 9, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luis Garcia-Larrea, Doctor 4 72 35 78 88 ext +33 larrea@univ-lyon1.fr
Contact: Nathalie André-Obadia, Doctor 4 72 35 70 68 ext +33 nathalie.obadia-andre@chu-lyon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02346396
Other Study ID Numbers  ICMJE 2014.869
2014-A01437-40 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP