Neurofeedback for Stroke Rehabilitation

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Other: Neurofeedback; Other: Sham Neurofeedback

• Registration Number: NCT03775915
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2018-02-09
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-14
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-20
• Status Verified: 2020-07
• Results First Submitted: 2021-06-11
• Results First Submitted QC: 2021-07-19
• Results First Posted: 2021-08-13
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real Neurofeedback	Neurofeedback	3 sessions of Real Neurofeedback over 1 week
Sham Neurofeedback	Sham Neurofeedback	3 sessions of Sham Neurofeedback over 1 week

Primary Outcome Measures

Name	Time	Method
Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)	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	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 Outcome Measures

Name	Time	Method
Change in Lateralisation of Brain Activity	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.
Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)	Throughout study completion, an average of 3 weeks	Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG
Upper Limb Function	Baseline, 1 week follow up	Action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function
Change in Upper Limb Function	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
Change in Resting State Functional Connectivity	1 week follow up	Change in resting state functional connectivity, assessed using fMRI Analysis still in progress
Change in Grey Matter Volume	Baseline, 1 week follow up	Change in grey matter volume derived from structural (T1) MRI Analysis still in progress
Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)	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.
Upper Limb Impairment	Baseline, 1 month follow up	Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment
Change in White Matter Tract Integrity	1 week follow up	Change in integrity of the white matter tracts, assessed using diffusion tensor imaging Analysis nearly completed
Change in White Matter Microstructure	1 week follow up	Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping

Trial Locations

Locations (1)

Wellcome Centre for Integrative Neuroimaging (WIN); 🇬🇧 Oxford, United Kingdom