Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-02-01 @ 3:21 AM
Study NCT ID:
NCT02844868
Status:
TERMINATED
Last Update Posted:
2022-10-19
First Post:
2016-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Observance and the Tolerance of a Motor Training Program
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTIMAH
Brief Summary:
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.
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.
Detailed Description:
During the initial 20 min of each session, 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. The pseudo stimulation reproduces during the first and the last 30 seconds of the stimulation, tingling feelings due to current flow experienced during tDCS. In this way there is no possibility for the patient to recognize the difference between the real and the placebo stimulation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-A01249-42 | OTHER | ANSM | View |