Neurofeedback for Stroke Rehabilitation

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-09

Study Completion Date

2020-03-20

Brief Summary

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Real-time neurofeedback aims to alter brain activation patterns through online feedback of ongoing brain activity using magnetic resonance imagining (MRI). Stroke survivors will be randomised to receive 3 sessions of real or sham neurofeedback. This study aims to investigate whether: 1) stroke survivors can maintain alterations in brain activity after the feedback is removed, 2) neurofeedback training leads to improvements in movement of the hand and arm, 3) neurofeedback training leads to changes in brain structure and function, 4) variability in response across people can be understood.

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Detailed Description

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Many stroke survivors experience impairment in upper limb function, reducing independence in activities of daily living. These impairments are associated with atypical brain activity patterns. Real-time neurofeedback aims to alter brain activation patterns through online feedback of ongoing brain activity using magnetic resonance imagining (MRI). Patterns of brain activity are displayed to a participant while a task is being performed. The participant is instructed to try to alter the patterns in a particular way, promoting specific brain activity patterns. Previous studies have found that people with and without stroke are capable of utilising the feedback to alter their brain activity. This study aims to investigate whether:

1. stroke survivors can maintain alterations in brain activity after the feedback is removed
2. neurofeedback training leads to improvements in movement of the hand and arm
3. neurofeedback training leads to changes in brain structure and function
4. variability in response across people can be understood.

30 stroke survivors (\> 6 months after stroke), with residual upper limb impairment, will be recruited between February 2018 and December 2020. Participants will be randomised to receive 3 sessions of real or sham neurofeedback over one week, taking place at the Wellcome Centre for Integrative Neuroimaging, University of Oxford. Changes in brain activity during affected hand movements will be assessed with and without feedback using functional MRI and after feedback sessions using electroencephalography (EEG). Brain connectivity and structure will also be assessed using MRI at baseline and at a follow-up one week later. Clinical measures of upper limb function and impairment will be performed at baseline and at follow up sessions one week and one month later (Action Research Arm Test, Fugl-Meyer upper limb assessment, Jebsen Taylor hand function test), and in each session following neurofeedback (Jebsen taylor test).

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly allocated (1:1 ratio) to either the intervention group (Real Neurofeedback) or the control group (Sham Neurofeedback). Randomisation is done after participants undergo baseline measurements using a computer-generated minimisation method that takes into account baseline upper limb function (Action Research Arm test score) and time since stroke.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Real Neurofeedback

3 sessions of Real Neurofeedback over 1 week

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type OTHER

A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.

Sham Neurofeedback

3 sessions of Sham Neurofeedback over 1 week

Group Type SHAM_COMPARATOR

Sham Neurofeedback

Intervention Type OTHER

A visual representation of brain activity pre-recorded from a previous participant

Interventions

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Neurofeedback

A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.

Intervention Type OTHER

Sham Neurofeedback

A visual representation of brain activity pre-recorded from a previous participant

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Stroke \> 6 months previously
* Unilateral upper limb impairment, but physically able to complete the tasks required

Exclusion Criteria

* Contraindications to MRI, such as a pacemaker, metallic implants or aneurysm clips
* Inability to provide informed consent
* Inability to actively participate in the research procedures

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No