HemiplegiaESTIMAHNCT02844868
Evaluation of the Observance and the Tolerance of a Motor Training Program
A study testing Active tDCS in people with Hemiplegia and Stroke, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiplegia, Stroke
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2018to 3 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hemiplegia, Stroke
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- stroke, hemiplegia, transcranial direct current stimulation (tDCS), rehabilitation, lower extremity, gait training
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
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 tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | During the first 20 min of training program, patient will have active tCDS (2 mA ) Receives: Device: Active tDCS |
| sham tDCS | Sham comparator | During the first 20 min of training program, patient will have sham tCDS Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
tDCS tolerance
tolerance questionnaire
Measured: 2 months
Secondary outcomes (1)
Effect size of TDCS on walking performance
Effect size on walking performance (Six-minute walk test (6MWT))
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start22 Feb 2018
- Primary completion31 Jan 2022
- Study completion3 Oct 2022
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal GIRAUX, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844868
- Sponsor's protocol ID
- 1608113
- Other IDs
- 2016-A01249-42
- Acronym
- ESTIMAH
- Status last verified
- Oct 2022
- First submitted
- 22 Jul 2016
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02844868
- Acronym / sponsor ID
- ESTIMAH / 1608113
- Conditions
- Hemiplegia, Stroke
- Keywords
- stroke, hemiplegia, transcranial direct current stimulation (tDCS), rehabilitation, lower extremity, gait training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCSDuring the first 20 min of training program, patient will have active tCDS (2 mA ) |
| sham tDCS | Sham comparator | Device: Sham tDCSDuring the first 20 min of training program, patient will have sham tCDS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSDuring 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. | Device | Active tDCS |
| Sham tDCSDuring 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. | Device | sham tDCS |
Primary outcome
tDCS tolerance
Time frame: 2 months
tolerance questionnaire
1 secondary outcome
Effect size of TDCS on walking performance
Time frame: 2 months
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal GIRAUX, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Hemiplegia and Stroke, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tDCS tolerance (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.