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

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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke; Hemiplegia
• Intervention / Treatment: Device: Active tDCS; Device: Sham tDCS

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tDCS tolerance	tolerance questionnaire	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect size of TDCS on walking performance	Effect size on walking performance (Six-minute walk test (6MWT))	2 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Pascal GIRAUX, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): October 3, 2022

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; hemiplegia; lower extremity; transcranial direct current stimulation (tDCS); gait training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: 1608113; 2016-A01249-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No