Brain Computer Interface Training After Stroke

NCT ID: NCT04071587

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2022-03-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Brain Computer Interface training

Intervention Type: DEVICE

Training with RecoveriX system.

Control

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Standard physiotherapy and occupational therapy according to clinical routines.

Interventions

Brain Computer Interface training

Training with RecoveriX system.

Intervention Type: DEVICE

Control

Standard physiotherapy and occupational therapy according to clinical routines.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hammel Neurorehabilitation Centre and University Research Clinic

OTHER

Sponsor Role: collaborator

Sygekassernes Helsefond

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iris Brunner, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, Hammel Neurocenter

Locations

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Aarhus, Denmark

Countries

Denmark

Other Identifiers

649780

Identifier Type: -

Identifier Source: org_study_id