Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844868
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Hemiplegia Stroke Device: Active tDCS Device: Sham tDCS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. tDCS tolerance [ Time Frame: 2 months ]
    tolerance questionnaire


Secondary Outcome Measures :
  1. Effect size of TDCS on walking performance [ Time Frame: 2 months ]
    Effect size on walking performance (Six-minute walk test (6MWT))



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having had a first ischemic stroke within 6 months.
  • 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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Pascal GIRAUX, MD (0)477127536 pascal.giraux@chu-st-etienne.fr
Contact: Diana RIMAUD (0)477120467 diana.rimaud@chu-st-etienne.fr

Locations
Layout table for location information
France
CHU de SAINT-ETIENNE Recruiting
Saint-etienne, France, 42000
Contact: Pascal GIRAUX, MD PhD         
Contact: Diana RIMAUD, CRA       diana.rimaud@chu-st-etienne.fr   
Sub-Investigator: Agnès CONDEMINE, MD         
Sub-Investigator: Caroline VOIRY, MD         
Principal Investigator: Pascal GIRAUX, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Layout table for investigator information
Principal Investigator: Pascal GIRAUX, MD CHU SAINT-ETIENNE

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02844868     History of Changes
Other Study ID Numbers: 1608113
2016-A01249-42 ( Other Identifier: ANSM )
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
stroke
hemiplegia
transcranial direct current stimulation (tDCS)
rehabilitation
lower extremity
gait training
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms