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Neurofeedback for Stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775915
Recruitment Status : Terminated (COVID-19 lockdown and halt of clinical trials)
First Posted : December 14, 2018
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Neurofeedback Other: Sham Neurofeedback Not Applicable

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:

  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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Real-Time fMRI and a Mobile EEG System to Provide Neurofeedback to Stroke Patients to Promote Neural Plasticity for Motor Rehabilitation.
Actual Study Start Date : February 9, 2018
Actual Primary Completion Date : March 20, 2020
Actual Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Real Neurofeedback
3 sessions of Real Neurofeedback over 1 week
Other: Neurofeedback
A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.

Sham Comparator: Sham Neurofeedback
3 sessions of Sham Neurofeedback over 1 week
Other: Sham Neurofeedback
A visual representation of brain activity pre-recorded from a previous participant




Primary Outcome Measures :
  1. Change in lateralisation of brain activity [ Time Frame: Throughout the 3 intervention sessions, an average of 4 days ]
    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.

  2. Change in hand function [ Time Frame: Throughout study completion, an average of 3 weeks ]
    Change in performance on the Jebsen Taylor hand function test (time, in seconds)


Secondary Outcome Measures :
  1. Change in lateralisation of brain activity [ Time Frame: 1 week follow up ]
    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.

  2. Change in lateralisation of brain activity during visuomotor squeeze task (MRI) [ Time Frame: 1 week follow up ]
    Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using functional magnetic resonance imaging (BOLD signal).

  3. Lateralisation of brain activity during visuomotor squeeze task (EEG) [ Time Frame: Throughout study completion, an average of 3 weeks ]
    Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG

  4. Change in upper limb function [ Time Frame: 1 week follow up ]
    Change in action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function

  5. Change in upper limb function [ Time Frame: 1 month follow up ]
    Change in action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function

  6. Change in upper limb impairment [ Time Frame: 1 week follow up ]
    Change in upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment

  7. Change in upper limb impairment [ Time Frame: 1 month follow up ]
    Change in upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment

  8. Change in resting state functional connectivity [ Time Frame: 1 week follow up ]
    Change in resting state functional connectivity, assessed using fMRI

  9. Change in white matter tract integrity [ Time Frame: 1 week follow up ]
    Change in integrity of the white matter tracts, assessed using diffusion tensor imaging

  10. Change in grey matter volume [ Time Frame: Baseline, 1 week follow up ]
    Change in grey matter volume derived from structural (T1) MRI

  11. Change in white matter microstructure [ Time Frame: 1 week follow up ]
    Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping


Other Outcome Measures:
  1. Baseline structure and function as a correlate of response to neurofeedback [ Time Frame: Throughout study completion, an average of 3 weeks. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775915


Locations
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United Kingdom
Wellcome Centre for Integrative Neuroimaging (WIN)
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
Wellcome Trust
Investigators
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Principal Investigator: Heidi Johansen-Berg, PhD University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03775915    
Other Study ID Numbers: StrokeNF
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymous data may be shared with other researchers on request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Motor function
Brain activity
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases