Brain Computer Interface Training After Stroke

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT04071587

Collaborator

Hammel Neurorehabilitation Centre and University Research Clinic (Other), Sygekassernes Helsefond (Other)

Enrollment

Location

Arms

40.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Brain Computer Interface training Behavioral: Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients are randomized to one of two treatment options, intervention or standard rehabilitationPatients are randomized to one of two treatment options, intervention or standard rehabilitation

Masking:

Single (Outcomes Assessor)

Masking Description:

All assessments will be done by assessors blinded to treatment allocation.

Primary Purpose:

Treatment

Official Title:

Brain Computer Interface Training for Patients With Severe Upper Limb Paresis in the Subacute Phase After Stroke

Actual Study Start Date :

Aug 26, 2019

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BCI training 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.	Device: Brain Computer Interface training Training with RecoveriX system.
Active Comparator: Control Patients randomized to this control group will receive standard physiotherapy and occupational therapy for their impaired upper limb.	Behavioral: Control Standard physiotherapy and occupational therapy according to clinical routines.

Arm

Intervention/Treatment

Experimental: BCI training

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.

Device: Brain Computer Interface training

Training with RecoveriX system.

Active Comparator: Control

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

Behavioral: Control

Standard physiotherapy and occupational therapy according to clinical routines.

Outcome Measures

Primary Outcome Measures

Action Research Arm Test (ARAT) [Upper limb function 90 days after stroke]
Upper limb function on a scale of 0 - 57 (best)

Secondary Outcome Measures

Fugl-Meyer Assessment (UL) [Upper limb impairment 90 days after stroke]
Upper limb impairment on a scale from 0-66 (best)
Functional Independence Measure [Functional independence 90 days after stroke]
Independence in activities og daily living, 18-126 (best)

Other Outcome Measures

Interviews [Through study completion, an average of 6 months]
Qualitative assessment of user experiences

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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