Neurofeedback for Stroke Rehabilitation

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03775915
• Other study ID #: StrokeNF
• Status: Terminated
• Phase: N/A
• Start date: February 9, 2018
• Est. completion date: March 20, 2020

Study information

• Verified date: July 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Neurofeedback
A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.
• Sham Neurofeedback
A visual representation of brain activity pre-recorded from a previous participant

Locations

Country	Name	City	State
United Kingdom	Wellcome Centre for Integrative Neuroimaging (WIN)	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline Structure and Function as a Correlate of Response to Neurofeedback	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.
Primary	Lateralisation of Brain Activity	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.	Throughout the 3 intervention sessions, an average of 4 days
Primary	Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)	Performance on the Jebsen Taylor hand function test (time, in seconds to complete specified activities reflecting daily living)	Throughout study completion, 5 assessment sessions spread over approximately 3 weeks
Secondary	Change in Lateralisation of Brain Activity	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.	1 week follow up
Secondary	Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)	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.	Baseline, 1 week follow up
Secondary	Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)	Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG	Throughout study completion, an average of 3 weeks
Secondary	Upper Limb Function	Action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function	Baseline, 1 week follow up
Secondary	Change in Upper Limb Function	Change in action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function	1 month follow up
Secondary	Upper Limb Impairment	Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment	Baseline, 1 week follow up
Secondary	Upper Limb Impairment	Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment	Baseline, 1 month follow up
Secondary	Change in Resting State Functional Connectivity	Change in resting state functional connectivity, assessed using fMRI Analysis still in progress	1 week follow up
Secondary	Change in White Matter Tract Integrity	Change in integrity of the white matter tracts, assessed using diffusion tensor imaging Analysis nearly completed	1 week follow up
Secondary	Change in Grey Matter Volume	Change in grey matter volume derived from structural (T1) MRI Analysis still in progress	Baseline, 1 week follow up
Secondary	Change in White Matter Microstructure	Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping	1 week follow up