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Completed

NCT Number: NCT04071587

Brain Computer Interface Training 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammel Neurorehabilitation Centre and University Research Clinic

Hammel, Aarhus, 8450, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain Computer Interface training

Device

Training with RecoveriX system.

Control

Behavioral

Standard physiotherapy and occupational therapy according to clinical routines.

Primary outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: Upper limb function 90 days after stroke

    Upper limb function on a scale of 0 - 57 (best)

Secondary outcomes

  1. Fugl-Meyer Assessment (UL)

    Time frame: Upper limb impairment 90 days after stroke

    Upper limb impairment on a scale from 0-66 (best)

  2. Functional Independence Measure

    Time frame: Functional independence 90 days after stroke

    Independence in activities og daily living, 18-126 (best)

Other outcomes

  1. Interviews

    Time frame: Through study completion, an average of 6 months

    Qualitative assessment of user experiences

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Hammel Neurorehabilitation Centre and University Research Clinic
  • Sygekassernes Helsefond

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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