- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03775915
Neurofeedback for Stroke Rehabilitation
The Use of Real-Time fMRI and a Mobile EEG System to Provide Neurofeedback to Stroke Patients to Promote Neural Plasticity for Motor Rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oxford, United Kingdom, OX3 9DU
- Wellcome Centre for Integrative Neuroimaging (WIN)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Real Neurofeedback
3 sessions of Real Neurofeedback over 1 week
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A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.
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Sham Comparator: Sham Neurofeedback
3 sessions of Sham Neurofeedback over 1 week
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A visual representation of brain activity pre-recorded from a previous participant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Throughout the 3 intervention sessions, an average of 4 days
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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
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Performance on the Jebsen Taylor hand function test (time, in seconds to complete specified activities reflecting daily living)
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Throughout study completion, 5 assessment sessions spread over approximately 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Lateralisation of Brain Activity
Time Frame: 1 week follow up
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Change in lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal.
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1 week follow up
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Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)
Time Frame: Throughout study completion, an average of 3 weeks
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Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG
|
Throughout study completion, an average of 3 weeks
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Change in Upper Limb Function
Time Frame: 1 month follow up
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Change in action research arm test score (ARAT; upper limb function).
Range 0-57, higher numbers indicate better upper limb function
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1 month follow up
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Change in Resting State Functional Connectivity
Time Frame: 1 week follow up
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Change in resting state functional connectivity, assessed using fMRI Analysis still in progress
|
1 week follow up
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Change in White Matter Tract Integrity
Time Frame: 1 week follow up
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Change in integrity of the white matter tracts, assessed using diffusion tensor imaging Analysis nearly completed
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1 week follow up
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Change in Grey Matter Volume
Time Frame: Baseline, 1 week follow up
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Change in grey matter volume derived from structural (T1) MRI Analysis still in progress
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Baseline, 1 week follow up
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Change in White Matter Microstructure
Time Frame: 1 week follow up
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Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping
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1 week follow up
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Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)
Time Frame: Baseline, 1 week follow up
|
Lateralisation of brain activity during a visuomotor squeeze task, assessed using functional magnetic resonance imaging (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.
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Baseline, 1 week follow up
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Upper Limb Function
Time Frame: Baseline, 1 week follow up
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Action research arm test score (ARAT; upper limb function).
Range 0-57, higher numbers indicate better upper limb function
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Baseline, 1 week follow up
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Upper Limb Impairment
Time Frame: Baseline, 1 week follow up
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Upper limb Fugl Meyer assessment score (upper limb impairment).
Range 0-66, higher numbers indicate less upper limb impairment
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Baseline, 1 week follow up
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Upper Limb Impairment
Time Frame: Baseline, 1 month follow up
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Upper limb Fugl Meyer assessment score (upper limb impairment).
Range 0-66, higher numbers indicate less upper limb impairment
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Baseline, 1 month follow up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Structure and Function as a Correlate of Response to Neurofeedback
Time Frame: Throughout study completion, an average of 3 weeks.
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The correlation between baseline measures and change in lateralisation of brain activity during movement of the affected hand will be tested in order to identify markers to explain variability in response to real neurofeedback. Analysis still in progress |
Throughout study completion, an average of 3 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Heidi Johansen-Berg, PhD, University of Oxford
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- StrokeNF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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