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Neurofeedback for Stroke Rehabilitation

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University of Oxford

Status

Terminated

Conditions

Stroke

Treatments

Other: Neurofeedback
Other: Sham Neurofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT03775915
StrokeNF

Details and patient eligibility

About

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.

Full 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:

stroke survivors can maintain alterations in brain activity after the feedback is removed neurofeedback training leads to improvements in movement of the hand and arm neurofeedback training leads to changes in brain structure and function 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).

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

27 participants in 2 patient groups

Real Neurofeedback
Experimental group
Description:
3 sessions of Real Neurofeedback over 1 week
Treatment:
Other: Neurofeedback
Sham Neurofeedback
Sham Comparator group
Description:
3 sessions of Sham Neurofeedback over 1 week
Treatment:
Other: Sham Neurofeedback

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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