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Brain Computer Interface Training After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Brain Computer Interface training
Control
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring BCI, upper limb, severe paresis, subacute stroke, rehabilitation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hammel Neurorehabilitation Centre and University Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BCI training

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Action Research Arm Test (ARAT)
Upper limb function on a scale of 0 - 57 (best)

Secondary Outcome Measures

Fugl-Meyer Assessment (UL)
Upper limb impairment on a scale from 0-66 (best)
Functional Independence Measure
Independence in activities og daily living, 18-126 (best)

Full Information

First Posted
August 21, 2019
Last Updated
November 10, 2022
Sponsor
University of Aarhus
Collaborators
Hammel Neurorehabilitation Centre and University Research Clinic, Sygekassernes Helsefond
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1. Study Identification

Unique Protocol Identification Number
NCT04071587
Brief Title
Brain Computer Interface Training After Stroke
Official Title
Brain Computer Interface Training for Patients With Severe Upper Limb Paresis in the Subacute Phase After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Hammel Neurorehabilitation Centre and University Research Clinic, Sygekassernes Helsefond

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
BCI, upper limb, severe paresis, subacute stroke, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized to one of two treatment options, intervention or standard rehabilitation
Masking
Outcomes Assessor
Masking Description
All assessments will be done by assessors blinded to treatment allocation.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCI training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients randomized to this control group will receive standard physiotherapy and occupational therapy for their impaired upper limb.
Intervention Type
Device
Intervention Name(s)
Brain Computer Interface training
Intervention Description
Training with RecoveriX system.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Standard physiotherapy and occupational therapy according to clinical routines.
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
Upper limb function on a scale of 0 - 57 (best)
Time Frame
Upper limb function 90 days after stroke
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment (UL)
Description
Upper limb impairment on a scale from 0-66 (best)
Time Frame
Upper limb impairment 90 days after stroke
Title
Functional Independence Measure
Description
Independence in activities og daily living, 18-126 (best)
Time Frame
Functional independence 90 days after stroke
Other Pre-specified Outcome Measures:
Title
Interviews
Description
Qualitative assessment of user experiences
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Brunner, PhD
Organizational Affiliation
Aarhus University, Hammel Neurocenter
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammel Neurorehabilitation Centre and University Research Clinic
City
Hammel
State/Province
Aarhus
ZIP/Postal Code
8450
Country
Denmark

12. IPD Sharing Statement

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Brain Computer Interface Training After Stroke

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