Brain-computer interface and neuromuscular stimulation for rehabilitation following chronic stroke
- Conditions
- I61 - Intracerebral haemorrhageI63 - Cerebral infarctionChronic condition (at least 10 months after occurrence of cerebrovascular accident)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-000755-97-Outside-EU/EEA
- Lead Sponsor
- Defitech Chair in Brain-Machine Interface, EPF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 32
1) Age more than 18 years-old
2) Victim of cerebrovascular accident (stroke)
3) Patients in their chronic phase, more than 10 months after stroke.
4) Severe paralysis of the arm
5) Ability to understand information and ability to give a free and informed consent
6) Good eyesight and hearing, or corrected
7) First stroke (infarction), preferably ischemic stroke
8) Unilateral cortical lesion (left or right hemisphere) or subcortical lesion, lesions of the supra-pontic corticospinal pathway causing a motor deficit of upper limb
9) Paresis / central paralysis of the upper limb (the intervention focuses on upper limb; The presence of other motor deficits is not a criterion of exclusion)
10) Ability to understand instructions to perform mental tasks, like mental imagery or attempt of motor activity (more specifically, the ability to imagine/attempt movements of the upper limbs). These capacities are estimated with neurophysiological assessments
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
1) Anything that hampers the proper EEG acquisition (for example, a skin contamination, scalp wound, dermatitis, uncontrolled/coarse muscle activity or an electrically noisy environment)
2) Heavy medication affecting the central nervous system (including vigilance)
3) Concomitant serious illnesses (comorbidity: fever, infection, metabolic, cardiac arrest)
4) Multiple infarctions
5) Complete unlilateral spatial neglect
6) Inability to perform mental and motor imagery tasks
7) Severe inability to understand and communicate (eg, severe aphasia), inability to understand the information given, the objectives of the study or instructions to perform tasks.
8) Inability to concentrate for 2 hours.
9) Severe dystonia / involuntary movements
10) Other concurrent neurological disorders (eg, Parkinson's disease)
11) High level of spasticity and / or pain
12) Pacemakers, other active implants such as pumps, pacemakers for pain or phrenic pacing
13) Severe or recent heart disease
14) Implants in the area of the flow of current under the FES electrodes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Improvement of mobility, to enable performance of daily tasks. To be evaluated and quantified using the Fugl-Meyer Assessment: motor arm. The test will be carried out before the therapy, at the end of the therapy, and 6 months after the therapy.;Secondary Objective: The following tests are carried out pre- and post-intervention:<br>- Medical Research Council Power Test<br>- National Institute of Health Stroke Scale (motor: Arm)<br>- European Stroke Scale<br>- Modified Ashworth Scale (spasticity)<br>- Neuropsychological profile (with Montreal Cognitive Assessment and other tests);Primary end point(s): 1) Pre-intevention<br>2) Post-intevention (3 to 5 weeks after begin of therapy)<br>3) Follow up (after 6 months);Timepoint(s) of evaluation of this end point: 1) Pre-intevention<br>2) Post-intevention (3 to 5 weeks after begin of therapy)<br>3) Follow up (after 6 months)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): There are no secondary end-points;Timepoint(s) of evaluation of this end point: There are no secondary end-points