Brain Computer Interface Training After Stroke

University of Aarhus

Status: Completed

Conditions: Stroke

Treatments: Device: Brain Computer Interface training; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04071587

649780

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

BCI training

Experimental group

Description:

Patients randomized to this group will receive up to12 (minimum 8) sessions of BCI training with the RecoveriX system (gtec, Austria). The system combines EEG driven functional electrical stimulation with visual feedback. BCI training is provided as a part of standard training of the impaired upper limb.

Treatment:

Device: Brain Computer Interface training

Control

Active Comparator group

Description:

Patients randomized to this control group will receive standard physiotherapy and occupational therapy for their impaired upper limb.

Treatment:

Behavioral: Control