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Evaluation of the Observance and the Tolerance of a Motor Training Program (ESTIMAH)

Primary Purpose

Hemiplegia, Stroke

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring stroke, hemiplegia, transcranial direct current stimulation (tDCS), rehabilitation, lower extremity, gait training

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having had a first ischemic stroke within 6 months, or have already had a stroke in the same lesion zone.
  • No recurrence.
  • Responsible of a right or left hemiplegia.
  • Able to walk alone with or without technical assistance.
  • Over a distance of at least 10 meters.
  • Performance on the six-minute walk test less than 400 meters.
  • Without neurological history other than stroke.

Exclusion Criteria:

  • Patients who did not have brain MRI after their stroke
  • Patients with complete lesion of the primary motor cortex (as identified on MRI).
  • Patients with an addiction to alcohol or drugs.
  • Patients with psychiatric disease, cognitive impairment disease, uncontrolled epilepsy, neoplastic disease, severe renal or pulmonary failure.
  • Patients with cerebellar syndrome associated.
  • Patients with clinical involvement of the brainstem (cranial nerve deficit).
  • Patients who refused to sign the written consent.
  • Patients who have an ongoing pregnancy.
  • Patients under justice protection.
  • Patients with contraindication to practice aerobic training after stress test.

Sites / Locations

  • CHU de SAINT-ETIENNE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

sham tDCS

Arm Description

During the first 20 min of training program, patient will have active tCDS (2 mA )

During the first 20 min of training program, patient will have sham tCDS

Outcomes

Primary Outcome Measures

tDCS tolerance
tolerance questionnaire

Secondary Outcome Measures

Effect size of TDCS on walking performance
Effect size on walking performance (Six-minute walk test (6MWT))

Full Information

First Posted
July 22, 2016
Last Updated
October 17, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02844868
Brief Title
Evaluation of the Observance and the Tolerance of a Motor Training Program
Acronym
ESTIMAH
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Stroke
Keywords
stroke, hemiplegia, transcranial direct current stimulation (tDCS), rehabilitation, lower extremity, gait training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
During the first 20 min of training program, patient will have active tCDS (2 mA )
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
During the first 20 min of training program, patient will have sham tCDS
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
tDCS tolerance
Description
tolerance questionnaire
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Effect size of TDCS on walking performance
Description
Effect size on walking performance (Six-minute walk test (6MWT))
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having had a first ischemic stroke within 6 months, or have already had a stroke in the same lesion zone. No recurrence. Responsible of a right or left hemiplegia. Able to walk alone with or without technical assistance. Over a distance of at least 10 meters. Performance on the six-minute walk test less than 400 meters. Without neurological history other than stroke. Exclusion Criteria: Patients who did not have brain MRI after their stroke Patients with complete lesion of the primary motor cortex (as identified on MRI). Patients with an addiction to alcohol or drugs. Patients with psychiatric disease, cognitive impairment disease, uncontrolled epilepsy, neoplastic disease, severe renal or pulmonary failure. Patients with cerebellar syndrome associated. Patients with clinical involvement of the brainstem (cranial nerve deficit). Patients who refused to sign the written consent. Patients who have an ongoing pregnancy. Patients under justice protection. Patients with contraindication to practice aerobic training after stress test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Observance and the Tolerance of a Motor Training Program

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