Clinical Trials Directory

Trials / Terminated

TerminatedNCT03775915

Neurofeedback for Stroke Rehabilitation

The Use of Real-Time fMRI and a Mobile EEG System to Provide Neurofeedback to Stroke Patients to Promote Neural Plasticity for Motor Rehabilitation.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
University of Oxford · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
OTHERNeurofeedbackA visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.
OTHERSham NeurofeedbackA visual representation of brain activity pre-recorded from a previous participant

Timeline

Start date
2018-02-09
Primary completion
2020-03-20
Completion
2020-03-20
First posted
2018-12-14
Last updated
2023-06-13
Results posted
2021-08-13

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03775915. Inclusion in this directory is not an endorsement.