Not provided
Not provided
Not provided
Not provided
Not provided
COVID-19 lockdown and halt of clinical trials
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real Neurofeedback | Experimental | 3 sessions of Real Neurofeedback over 1 week |
|
| Sham Neurofeedback | Sham Comparator | 3 sessions of Sham Neurofeedback over 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback | Other | A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week follow up |
| Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Structure and Function as a Correlate of Response to Neurofeedback | The correlation between baseline measures and change in lateralisation of brain activity during movement of the affected hand will be tested in order to identify markers to explain variability in response to real neurofeedback. Analysis still in progress | Throughout study completion, an average of 3 weeks. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heidi Johansen-Berg, PhD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellcome Centre for Integrative Neuroimaging (WIN) | Oxford | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35960166 | Derived | 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. |
Not provided
Not provided
Anonymous data may be shared with other researchers on request
Analysis code may be shared following publication of the study results. There is no set end date for this
Upon reasonable request to the PI
Not provided
3 participants were not randomised to a group. 1 was withdrawn because the location of their stroke lesion made it impossible to deliver the intervention. 1 withdrew because they did not like the MRI scan. 1 was unable to continue due to study suspension because of the coronavirus pandemic.
Participants were recruited from the community, between February 2018 and March 2020
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Real Neurofeedback | 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner. |
| FG001 | Sham Neurofeedback | 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Real Neurofeedback | 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner. |
| BG001 | Sham Neurofeedback |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | laterality index adjusted for baseline | Throughout the 3 intervention sessions, an average of 4 days |
|
2 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real Neurofeedback | 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Melanie Fleming, Research Associate | University of Oxford | +441865611461 | melanie.fleming@ndcn.ox.ac.uk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2021 | Jun 10, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Sham Neurofeedback | Other | A visual representation of brain activity pre-recorded from a previous participant |
|
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. |
| 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 | 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 | 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 | 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 | 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 | Baseline, 1 month follow up |
| Change in Resting State Functional Connectivity | Change in resting state functional connectivity, assessed using fMRI Analysis still in progress | 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 | 1 week follow up |
| Change in Grey Matter Volume | Change in grey matter volume derived from structural (T1) MRI Analysis still in progress | Baseline, 1 week follow up |
| Change in White Matter Microstructure | Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping | 1 week follow up |
3 sessions of Sham Neurofeedback over 1 week
Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Affected Hand | Right, Left | Count of Participants | Participants |
|
| Time since stroke | Mean | Standard Deviation | months |
|
| OG001 |
| Sham Neurofeedback |
3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant |
|
|
|
| Primary | 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) | Posted | Mean | Standard Error | seconds | Throughout study completion, 5 assessment sessions spread over approximately 3 weeks |
|
|
|
|
| Secondary | 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. | Not Posted | 1 week follow up | Participants |
| Secondary | 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. | Outliers removed on the basis of head motion or laterality index greater than 2 standard deviations from the mean | Posted | Mean | Standard Error | laterality index | Baseline, 1 week follow up |
|
|
|
| Secondary | Lateralisation of Brain Activity During Visuomotor Squeeze Task (EEG) | Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG | Not Posted | Throughout study completion, an average of 3 weeks | Participants |
| Secondary | Upper Limb Function | Action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function | Posted | Mean | Standard Error | score on a scale | Baseline, 1 week follow up |
|
|
|
| Secondary | 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 | Only participants who were able to attend the 1 month follow up are included | Posted | Mean | Standard Error | score on a scale | 1 month follow up |
|
|
|
| Secondary | Upper Limb Impairment | Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment | Posted | Mean | Standard Error | score on a scale | Baseline, 1 week follow up |
|
|
|
| Secondary | Upper Limb Impairment | Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment | Only participants who were able to attend the 1 month follow up are included | Posted | Mean | Standard Error | score on a scale | Baseline, 1 month follow up |
|
|
|
| Secondary | Change in Resting State Functional Connectivity | Change in resting state functional connectivity, assessed using fMRI Analysis still in progress | Not Posted | Jul 2024 | 1 week follow up | Participants |
| Secondary | Change in White Matter Tract Integrity | Change in integrity of the white matter tracts, assessed using diffusion tensor imaging Analysis nearly completed | Not Posted | Jul 2024 | 1 week follow up | Participants |
| Secondary | Change in Grey Matter Volume | Change in grey matter volume derived from structural (T1) MRI Analysis still in progress | Not Posted | Jul 2024 | Baseline, 1 week follow up | Participants |
| Secondary | Change in White Matter Microstructure | Change in white matter microstructure, specifically myelin content, assessed using MRI Multi-Parameter Mapping | Not Posted | 1 week follow up | Participants |
| Other Pre-specified | Baseline Structure and Function as a Correlate of Response to Neurofeedback | The correlation between baseline measures and change in lateralisation of brain activity during movement of the affected hand will be tested in order to identify markers to explain variability in response to real neurofeedback. Analysis still in progress | Not Posted | Jul 2024 | Throughout study completion, an average of 3 weeks. | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Sham Neurofeedback | 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| Day3 |
|
| Day4 |
|
| Day5 |
|