Clinical trial NCT03775915: Neurofeedback for Stroke Rehabilitation
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Motor function
Brain activity
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2018-12-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Lateralisation of Brain Activity
timeFrame: Throughout the 3 intervention sessions, an average of 4 days
measure: Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)
timeFrame: Throughout study completion, 5 assessment sessions spread over approximately 3 weeks
Secondary outcomes:
measure: Change in Lateralisation of Brain Activity
timeFrame: 1 week follow up
measure: Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)
timeFrame: Baseline, 1 week follow up
measure: Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)
timeFrame: Throughout study completion, an average of 3 weeks
measure: Upper Limb Function
timeFrame: Baseline, 1 week follow up
measure: Change in Upper Limb Function
timeFrame: 1 month follow up
measure: Upper Limb Impairment
timeFrame: Baseline, 1 week follow up
measure: Upper Limb Impairment
timeFrame: Baseline, 1 month follow up
measure: Change in Resting State Functional Connectivity
timeFrame: 1 week follow up
measure: Change in White Matter Tract Integrity
timeFrame: 1 week follow up
measure: Change in Grey Matter Volume
timeFrame: Baseline, 1 week follow up
measure: Change in White Matter Microstructure
timeFrame: 1 week follow up
Other outcomes:
measure: Baseline Structure and Function as a Correlate of Response to Neurofeedback
timeFrame: Throughout study completion, an average of 3 weeks.
Locations:
city: Oxford
country: United Kingdom
facility: Wellcome Centre for Integrative Neuroimaging (WIN)
Study officials:
affiliation: University of Oxford
name: Heidi Johansen-Berg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanders ZB, Fleming MK, Smejka T, Marzolla MC, Zich C, Rieger SW, Luhrs M, Goebel R, Sampaio-Baptista C, Johansen-Berg H. Self-modulation of motor cortex activity after stroke: a randomized controlled trial. Brain. 2022 Oct 21;145(10):3391-3404. doi: 10.1093/brain/awac239.