NCT04071587

Brain Computer Interface Training After Stroke

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Brain Computer Interface training	Training with RecoveriX system.
BEHAVIORAL	Control	Standard physiotherapy and occupational therapy according to clinical routines.

Timeline

• Start date: 2019-08-26
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2019-08-28
• Last updated: 2022-11-14

Locations

1 site across 1 country: Denmark