The Use of Real-Time fMRI and a Mobile EEG System to Provide Neurofeedback to Stroke Patients to Promote Neural Plasticity for Motor Rehabilitation.
Phase: NA
Conditions: Stroke
Sponsor: University of Oxford

 
Study Title: Neurofeedback for Stroke Rehabilitation 
 
NCT: 03775915 
 
 
 
Chief/Principal Investigator: Professor Heidi Johansen-Berg, Wellcome Centre 
for Integrative Neuroimaging, University of Oxford 
 
Trial manager: Dr Melanie Fleming, Wellcome Centre for Integrative 
Neuroimaging, University of Oxford 
 
Sponsor: The University of Oxford 
 
 
 
 
Protocol summary – 10th June 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Summary of Study Design 
 
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. 
 
The training will consist of 3 real time functional MRI (rtFMRI) training sessions. Baseline 
measures will be taken prior to the start of the first session and post-training measures will 
be taken after the final training session.  
 
Primary and Secondary Endpoints/Outcome Measures 
 
The primary outcome measures are a change in motor function in the neurofeedback group 
compared to the control group and changes in brain activity during neurofeedback. These 
outcome measures will address whether the neural plasticity brought about by the 
neurofeedback can lead to subsequent behavioural improvements. 
 
The secondary outcome measures will be performance on visuo-motor tasks (visually cued 
grip force), motor impairment and measures of change in brain structure and function.  
 
Study Participants 
 
Patients who have had a stroke more than 6 months previously, that has affected their 
motor function of their upper limb.  
 
Inclusion Criteria: 
• 
Participant is willing and able to give informed consent for participation in the study. 
• 
Participant can understand verbal and written instructions in English. 

• 
Male or Female, aged > 18 years 
• 
Patient will have had symptomatic stroke that has affected the upper limb of one 
side of their body 
• 
Patients must have some residual movement in their affected limb. 
 
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 Procedures 
 
Written informed consent will be taken at the start of the first session by an experimenter 
trained in good clinical practice (GCP). A number of baseline measures of motor and neural 
function will then be performed. These tests will then be followed by the training sessions 
where participants will receive real or sham neurofeedback while performing a motor skill 
with their affected hand. Following the training sessions, the post-test session will repeat 
the motor and neural measures performed during baseline.  
 
Number of Participants 
 
The sample size (n=30) was selected to ensure there was sufficient data given issues in data 
quality or participant retention. In most FMRI studies it is recommended that there be at 
minimum 12 participants in each group (e.g., sham vs. treatment) (Desmond & Glover, 
2002). 
 
Analysis of Endpoints  
 
MR analysis will be performed using a common approach, using the FMRIB Software Library. 
EEG analysis will be performed similarly using a common approach using EEGlab software 
for Matlab. 
 

Statistical analysis of derived data will be performed using SPSS Statistics for Mac and 
MATLAB/R. Behavioural (e.g., Jebsen Taylor test, Action Research Arm Test) and EEG 
outcome measures will be assessed across sessions using a mixed-ANOVA (or linear mixed 
model as appropriate) with group (real vs sham) as a between-subjects variable and session 
as a within-subjects variable. Behavioural outcomes will also be correlated with neurological 
changes over training.