Clinical trial NCT04071587: Brain Computer Interface Training After Stroke
Official title: Brain Computer Interface Training for Patients With Severe Upper Limb Paresis in the Subacute Phase After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: BCI
upper limb
severe paresis
subacute stroke
rehabilitation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Hammel Neurorehabilitation Centre and University Research Clinic
name: Sygekassernes Helsefond
First posted: 2019-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to one of two treatment options, intervention or standard rehabilitation
Primary purpose: TREATMENT

Brief summary: In this study, we want to examine the effect of a new treatment approach for patients with severe upper limb paresis in the subacute phase after stroke. Brain Computer Interface (BCI) driven functional electrical stimulation will be compared to conventional training.

Detailed description: A randomized controlled pilot study will be conducted. Forty patients with severe UL paresis will be included. Patients with severe hemiparesis after stroke will be allocated to one of two treatment groups by a computerized randomization program. Patients in the intervention group will receive training with a BCI system paired with functional electrical stimulation and visual feedback (RecoveriX, gtec, Austria) as part of their rehabilitation. The targeted number of training sessions in the intervention group is 12. Patients in the control group will receive conventional upper limb training. All patients will receive other rehabilitation according to their needs.

Patients will be assessed by blinded raters before and after the intervention and 3 months post stroke. Main endpoint will be UL motor function assessed by Action Research Arm Test (ARAT) at 3 months post stroke. Other outcome measures comprise Fugl Meyer Motor Assessment and Functional Independence Measure. The patients and therapists' experience with this type of training will be evaluated with questionnaires and interviews.

Eligibility criteria: Inclusion Criteria:

* First ever or former stroke without UL motor residuals as confirmed by CT and / or MRI
* 15 days to 60 days (+/- 3) after stroke onset
* Severe paresis or paralysis defined as \< 13 on Action Research arm Test (ARAT)
* Able to give informed consent
* Able to comply with treatment protocol.

Exclusion Criteria:

* Other conditions limiting functional use of the affected UL,
* Psychiatric / behavioral conditions that interfere with compliance to the protocol, epilepsy

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Upper limb function 90 days after stroke
Secondary outcomes:
measure: Fugl-Meyer Assessment (UL)
timeFrame: Upper limb impairment 90 days after stroke
measure: Functional Independence Measure
timeFrame: Functional independence 90 days after stroke
Other outcomes:
measure: Interviews
timeFrame: Through study completion, an average of 6 months
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation Centre and University Research Clinic
state: Aarhus
Study officials:
affiliation: Aarhus University, Hammel Neurocenter
name: Iris Brunner, PhD
role: PRINCIPAL_INVESTIGATOR
References: