Evaluation of the Observance and the Tolerance of a Motor Training Program (ESTIMAH)
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|ClinicalTrials.gov Identifier: NCT02844868|
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : July 9, 2019
Transcortical direct current stimulation (tDCS) is an emerging technique in the rehabilitation of hemiplegic patients after stroke.
This study aims to assess the observance and the tolerance of repeated tDCS stimulation over the primary motor cortex of the lower limb coupled to a motor training program, among hemiplegic patients at the sub-acute stage. This is a prospective, randomized, double-blind, study with two parallel groups of 15 subjects each. The study will analyze first, the patient's observance considered good if 75% of the patients completed the entire protocol duration and the tolerance through a questionnaire. The secondary end point will try to estimate, if possible, the effect size of the walking performance measured with the six-minute walk test and aerobic performance measured with VO2peak of this training program compared to the same program combine with placebo stimulations. These evaluations are performed before, during and after the rehabilitation program.
|Condition or disease||Intervention/treatment||Phase|
|Hemiplegia Stroke||Device: Active tDCS Device: Sham tDCS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the Observance and the Tolerance of a Motor Training Program Combining With Repetitive tDCS Sessions on Walking Performance of Hemiplegic Stroke Patients at the Subacute Stage Post Stroke. ESTIMAH Study|
|Actual Study Start Date :||February 22, 2018|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Active tDCS
During the first 20 min of training program, patient will have active tCDS (2 mA )
Device: Active tDCS
During the first 20 min of training program, patient will have active tCDS : the patient received a 2 mA anodal tDCS over the lower limb ipsilesional motor area. The anodal electrode was positioned on the hotspot previously identified with TMS. The cathode was placed above the contralesional orbit.
Sham Comparator: sham tDCS
During the first 20 min of training program, patient will have sham tCDS
Device: Sham tDCS
During the first 20 min of training program, patient will have sham tCDS : the patient received a 2 mA anodal tDCS (only during the first and the last 30 seconds of the stimulation) and then, patient will have sham tDCS. The anodal electrode was positioned on the hotspot previously identified with TMS. The cathode was placed above the contralesional orbit.
- tDCS tolerance [ Time Frame: 2 months ]tolerance questionnaire
- Effect size of TDCS on walking performance [ Time Frame: 2 months ]Effect size on walking performance (Six-minute walk test (6MWT))
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): NCT02844868
|Contact: Pascal GIRAUX, MD||(0)firstname.lastname@example.org|
|Contact: Diana RIMAUD||(0)email@example.com|
|CHU de SAINT-ETIENNE||Recruiting|
|Saint-etienne, France, 42000|
|Contact: Pascal GIRAUX, MD PhD|
|Contact: Diana RIMAUD, CRA firstname.lastname@example.org|
|Sub-Investigator: Agnès CONDEMINE, MD|
|Sub-Investigator: Caroline VOIRY, MD|
|Principal Investigator: Pascal GIRAUX, MD PhD|
|Principal Investigator:||Pascal GIRAUX, MD||CHU SAINT-ETIENNE|