StrokeNCT03775915

Neurofeedback for Stroke Rehabilitation

A study testing Neurofeedback in people with Stroke, run by University of Oxford at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: Neurofeedback
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited Kingdom
Study dates: 9 Feb 2018to 20 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United Kingdom1 site

Wellcome Centre for Integrative Neuroimaging (WIN)
Oxford, OX3 9DU

Other trials in United Kingdom

About this study

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.

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.

Read the 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:

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).

Conditions: Stroke
Being tested: Neurofeedback, Sham Neurofeedback
Keywords: Motor function, Brain activity
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeurofeedbackOther
A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.
Sham NeurofeedbackOther
A visual representation of brain activity pre-recorded from a previous participant

Study groups in NCT03775915
Study group	Role	What they receive
Real Neurofeedback	Experimental	3 sessions of Real Neurofeedback over 1 week Receives: Other: Neurofeedback
Sham Neurofeedback	Sham comparator	3 sessions of Sham Neurofeedback over 1 week Receives: Other: Sham Neurofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
Measured: Throughout study completion, 5 assessment sessions spread over approximately 3 weeks

Secondary outcomes (11)

Change in Lateralisation of Brain Activity
Change in lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal.
Measured: 1 week follow up
Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)
Lateralisation of brain activity during a visuomotor squeeze task, assessed using functional magnetic resonance imaging (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.
Measured: Baseline, 1 week follow up
Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)
Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG
Measured: Throughout study completion, an average of 3 weeks
Upper Limb Function
Action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function
Measured: Baseline, 1 week follow up
Change in Upper Limb Function
Change in action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function
Measured: 1 month follow up
Upper Limb Impairment
Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment
Measured: Baseline, 1 week follow up
Upper Limb Impairment
Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment
Measured: Baseline, 1 month follow up
Change in Resting State Functional Connectivity
Change in resting state functional connectivity, assessed using fMRI Analysis still in progress
Measured: 1 week follow up
Change in White Matter Tract Integrity
Change in integrity of the white matter tracts, assessed using diffusion tensor imaging Analysis nearly completed
Measured: 1 week follow up
Change in Grey Matter Volume
Change in grey matter volume derived from structural (T1) MRI Analysis still in progress
Measured: Baseline, 1 week follow up
Change in White Matter Microstructure
Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping
Measured: 1 week follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Feb 201820 Mar 2020

First posted14 Dec 2018
Study start9 Feb 2018
Primary completion20 Mar 2020
Study completion20 Mar 2020

Why it stopped: COVID-19 lockdown and halt of clinical trials

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by University of OxfordThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03775915
Sponsor's protocol ID: StrokeNF
Status last verified: Jul 2020
First submitted: 6 Dec 2018
Last updated: 13 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymous data may be shared with other researchers on request

Publications

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.
PubMed 35960166

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03775915
Acronym / sponsor ID: StrokeNF
Conditions: Stroke
Keywords: Motor function, Brain activity
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID-19 lockdown and halt of clinical trials
Enrolment: 27 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Collaborators: Wellcome Trust
Study start: 9 Feb 2018 (actual)
Primary completion: 20 Mar 2020 (actual)
Study completion: 20 Mar 2020 (actual)
First posted: 14 Dec 2018 (actual)
Results: Posted 13 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Real Neurofeedback	Experimental	Other: Neurofeedback3 sessions of Real Neurofeedback over 1 week
Sham Neurofeedback	Sham comparator	Other: Sham Neurofeedback3 sessions of Sham Neurofeedback over 1 week

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NeurofeedbackA visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Other	Real Neurofeedback
Sham NeurofeedbackA visual representation of brain activity pre-recorded from a previous participant	Other	Sham Neurofeedback

Primary outcome

Lateralisation of Brain Activity
Time frame: Throughout the 3 intervention sessions, an average of 4 days
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.
Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)
Time frame: Throughout study completion, 5 assessment sessions spread over approximately 3 weeks
Performance on the Jebsen Taylor hand function test (time, in seconds to complete specified activities reflecting daily living)

11 secondary outcomes

Change in Lateralisation of Brain Activity
Time frame: 1 week follow up
Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI)
Time frame: Baseline, 1 week follow up
Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG)
Time frame: Throughout study completion, an average of 3 weeks
Upper Limb Function
Time frame: Baseline, 1 week follow up
Change in Upper Limb Function
Time frame: 1 month follow up
Upper Limb Impairment
Time frame: Baseline, 1 week follow up
Upper Limb Impairment
Time frame: Baseline, 1 month follow up
Change in Resting State Functional Connectivity
Time frame: 1 week follow up
Change in White Matter Tract Integrity
Time frame: 1 week follow up
Change in Grey Matter Volume
Time frame: Baseline, 1 week follow up
Change in White Matter Microstructure
Time frame: 1 week follow up

Results and safety

Results posted to the registry on 13 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Real Neurofeedback	12	12
Sham Neurofeedback	12	12

Primary outcome: Lateralisation of Brain Activity

Time frame: Throughout the 3 intervention sessions, an average of 4 days. Mean (95% Confidence Interval). Unit: laterality index adjusted for baseline

Measure	Real Neurofeedback n = 12	Sham Neurofeedback n = 12
Day 2	0.23 (0.15 to 0.31)	0.30 (0.22 to 0.39)
Day 3	0.26 (0.17 to 0.34)	0.22 (0.13 to 0.31)
Day 4	0.25 (0.17 to 0.34)	0.25 (0.16 to 0.34)

Real Neurofeedback vs Sham Neurofeedback: p >0.05, Linear Mixed Model

Primary outcome: Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds)

Time frame: Throughout study completion, 5 assessment sessions spread over approximately 3 weeks. Mean (Standard Error). Unit: seconds

Measure	Real Neurofeedback n = 12	Sham Neurofeedback n = 12
Day1	267 (73)	274 (77)
Day2	238 (64)	270 (77)
Day3	221 (59)	267 (75)
Day4	220 (61)	233 (64)
Day5	214 (61)	249 (70)

Real Neurofeedback vs Sham Neurofeedback: p >0.05, Mixed Models Analysis

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Real Neurofeedback	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Sham Neurofeedback	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35960166Sanders 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.
Individual participant dataSharing planned: Yes. Anonymous data may be shared with other researchers on request

Related trials for Stroke

Recruiting
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Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
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A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heidi Johansen-Berg, PhD principal investigator

University of Oxford

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Neurofeedback in people with Stroke, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lateralisation of Brain Activity (time frame: Throughout the 3 intervention sessions, an average of 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03775915, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.