The Use of Real-Time fMRI and a Mobile EEG System to Provide Neurofeedback to Stroke Patients to Promote Neural Plasticity for Motor Rehabilitation.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Oxford
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)
Study Overview
Brief Summary
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.
Detailed Description
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:
- stroke survivors can maintain alterations in brain activity after the feedback is removed
- neurofeedback training leads to improvements in movement of the hand and arm
- neurofeedback training leads to changes in brain structure and function
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)
Time Frame: Throughout study completion, 5 assessment sessions spread over approximately 3 weeks
Performance on the Jebsen Taylor hand function test (time, in seconds to complete specified activities reflecting daily living)
Lateralisation of Brain Activity
Time Frame: Throughout the 3 intervention sessions, an average of 4 days
Lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal. The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.
Secondary Outcomes
- Change in Lateralisation of Brain Activity(1 week follow up)
- Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)(Throughout study completion, an average of 3 weeks)
- Upper Limb Function(Baseline, 1 week follow up)
- Change in Upper Limb Function(1 month follow up)
- Change in Resting State Functional Connectivity(1 week follow up)
- Change in Grey Matter Volume(Baseline, 1 week follow up)
- Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)(Baseline, 1 week follow up)
- Upper Limb Impairment(Baseline, 1 month follow up)
- Change in White Matter Tract Integrity(1 week follow up)
- Change in White Matter Microstructure(1 week follow up)