Brain Computer Interface Training After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071587
• Other study ID #: 649780
• Status: Completed
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Brain Computer Interface training
Training with RecoveriX system.

Behavioral:
• Control
Standard physiotherapy and occupational therapy according to clinical routines.

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation Centre and University Research Clinic	Hammel	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Hammel Neurorehabilitation Centre and University Research Clinic, Sygekassernes Helsefond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interviews	Qualitative assessment of user experiences	Through study completion, an average of 6 months
Primary	Action Research Arm Test (ARAT)	Upper limb function on a scale of 0 - 57 (best)	Upper limb function 90 days after stroke
Secondary	Fugl-Meyer Assessment (UL)	Upper limb impairment on a scale from 0-66 (best)	Upper limb impairment 90 days after stroke
Secondary	Functional Independence Measure	Independence in activities og daily living, 18-126 (best)	Functional independence 90 days after stroke