Neurofeedback for Stroke Rehabilitation

NCT03775915 | Terminated Results

• 1 other identifier: StrokeNF
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Motor function; Brain activity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (11)

• Change in Lateralisation of Brain Activity

  1 week follow up

• Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)

  Baseline, 1 week follow up

• Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)

  Throughout study completion, an average of 3 weeks

• Upper Limb Function

  Baseline, 1 week follow up

• Change in Upper Limb Function

  1 month follow up

Other Outcomes (1)

• Baseline Structure and Function as a Correlate of Response to Neurofeedback

  Throughout study completion, an average of 3 weeks.

Study Arms (2)

Real Neurofeedback

EXPERIMENTAL

3 sessions of Real Neurofeedback over 1 week

Other: Neurofeedback

Sham Neurofeedback

SHAM COMPARATOR

3 sessions of Sham Neurofeedback over 1 week

Other: Sham Neurofeedback

Interventions

Neurofeedback OTHER

A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.

Real Neurofeedback

Sham Neurofeedback OTHER

A visual representation of brain activity pre-recorded from a previous participant

Sham Neurofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke \> 6 months previously
• Unilateral upper limb impairment, but physically able to complete the tasks required

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Wellcome Trust: collaborator

Study Sites (1)

Wellcome Centre for Integrative Neuroimaging (WIN)

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35960166 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Limitations and Caveats

Early termination due to COVID leading to smaller numbers enrolled in the study than originally planned. Interim analysis at the stopping point revealed results that were deemed unlikely to change with additional participants and so the study was closed and full analysis is in progress.

Results Point of Contact

• Title: Dr Melanie Fleming, Research Associate
• Organization: University of Oxford

melanie.fleming@ndcn.ox.ac.uk

+441865611461

Study Officials

• Heidi Johansen-Berg, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 14, 2018
• Study Start: February 9, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: June 13, 2023
• Results First Posted: August 13, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Analysis code may be shared following publication of the study results. There is no set end date for this
• Access Criteria: Upon reasonable request to the PI

Locations

GB (1)