Brain Computer Interface Training After Stroke

November 10, 2022 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus
      • Hammel, Aarhus, Denmark, 8450
        • Hammel neurorehabilitation centre and university research clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test (ARAT)
Time Frame: Upper limb function 90 days after stroke
Upper limb function on a scale of 0 - 57 (best)
Upper limb function 90 days after stroke

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interviews
Time Frame: Through study completion, an average of 6 months
Qualitative assessment of user experiences
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Sygekassernes Helsefond
Hammel Neurorehabilitation Centre and University Research Clinic

Investigators

  • Principal Investigator: Iris Brunner, PhD, Aarhus University, Hammel Neurocenter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 26, 2019

Primary Completion (ACTUAL)

March 31, 2022

Study Completion (ACTUAL)

March 31, 2022

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 649780

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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