Brain-computer interface and neuromuscular stimulation for rehabilitation following chronic stroke

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2017-000755-97-Outside-EU/EEA
• Date of registration: 16/03/2017
• Prospective Registration: Yes
• Primary sponsor: Defitech Chair in Brain-Machine Interface, EPFL
• Public title: Brain-computer interface and neuromuscular stimulation for rehabilitation following chronic stroke
• Scientific title: Brain-computer interface and neuromuscular stimulation for rehabilitation following chronic stroke - BCI-NMES-CVA
• Target sample size: 32
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000755-97
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: NMES of control group driven by "sham" BCI Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Switzerland

Contacts

• Name: CNBI, EPFL
• Affiliation: Defitech Chair in Brain-Machine Interface, EPFL

• Name: CNBI, EPFL
• Affiliation: Defitech Chair in Brain-Machine Interface, EPFL

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

I61 - Intracerebral haemorrhage I63 - Cerebral infarction Chronic condition (at least 10 months after occurrence of cerebrovascular accident)

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: BCI+NMES therapy
Product Code: BCINMES
Pharmaceutical Form: Cutaneous patch

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: 1) Pre-intevention
2) Post-intevention (3 to 5 weeks after begin of therapy)
3) Follow up (after 6 months)

Primary end point(s): 1) Pre-intevention
2) Post-intevention (3 to 5 weeks after begin of therapy)
3) Follow up (after 6 months)

Secondary Objective: The following tests are carried out pre- and post-intervention:
- Medical Research Council Power Test
- National Institute of Health Stroke Scale (motor: Arm)
- European Stroke Scale
- Modified Ashworth Scale (spasticity)
- Neuropsychological profile (with Montreal Cognitive Assessment and other tests)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: There are no secondary end-points

Secondary end point(s): There are no secondary end-points

Secondary ID(s)

EPFL-CNBI-2017-01

Source(s) of Monetary Support

Defitech Chair in Brain-Machine Interface, EPFL