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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Device: tDCS (use at home) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Non-invasive Analgesic Stimulation of the Motor Cortex at Home
Actual Study Start Date : February 9, 2015
Estimated Primary Completion Date : November 9, 2023
Estimated Study Completion Date : November 9, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346396


Contacts
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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

Locations
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France
Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD) Recruiting
Bron, France, 69500
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   
Principal Investigator: Luis Garcia-Larrea, Doctor         
Sub-Investigator: Nathalie André-Obadia, Doctor         
Principal Investigator: Patrick Mertens         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02346396    
Other Study ID Numbers: 2014.869
2014-A01437-40 ( Other Identifier: ID-RCB )
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Keywords provided by Hospices Civils de Lyon:
neuropathic pain
neurostimulation
ambulatory use
tDCS
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations