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 : Unknown
Verified October 2018 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : January 27, 2015
Last Update Posted : October 29, 2018
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Non-invasive Analgesic Stimulation of the Motor Cortex at Home|
|Actual Study Start Date :||February 9, 2015|
|Estimated Primary Completion Date :||October 9, 2020|
|Estimated Study Completion Date :||October 9, 2020|
|Experimental: Patients with neuropathic chronic pain||
Device: tDCS (use at home)
During 4 weeks (every week : 20 minutes / day during 5 days)
- 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) ]
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
|Contact: Luis Garcia-Larrea, Doctor||4 72 35 78 88 ext +email@example.com|
|Contact: Nathalie André-Obadia, Doctor||4 72 35 70 68 ext +firstname.lastname@example.org|
|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 email@example.com|
|Contact: Nathalie André-Obadia, Doctor 4 72 35 70 68 ext +33 firstname.lastname@example.org|
|Principal Investigator: Luis Garcia-Larrea, Doctor|
|Sub-Investigator: Nathalie André-Obadia, Doctor|
|Principal Investigator: Patrick Mertens|