Brain Computer Interface Training After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Brain Computer Interface training; Behavioral: Control

• Registration Number: NCT04071587
• Lead Sponsor: University of Aarhus

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-08-21
• Study Start: 2019-08-26
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Status Verified: 2022-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCI training	Brain Computer Interface 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.
Control	Control	Patients randomized to this control group will receive standard physiotherapy and occupational therapy for their impaired upper limb.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Hammel Neurorehabilitation Centre and University Research Clinic; 🇩🇰 Hammel, Aarhus, Denmark