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| ID | Type | Description | Link |
|---|---|---|---|
| A539300 | Other Identifier | UW Madison | |
| SMPH/RADIOLOGY | Other Identifier | UW Madison | |
| 15GRNT25780033 | Other Grant/Funding Number | American Heart Association | |
| Protocol Version 2/1/22 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The purpose of this research is to determine if two non-invasive brain stimulation techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can increase the extent of stroke recovery.
The aim of this study is to determine if functional muscle stimulation, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI).
Adult stroke patients with upper extremity motor impairments (henceforth "experimental group"), healthy controls, and participants with risk factors for stroke, without upper extremity impairment (allowing them to serve as controls for patients with upper extremity impairments (henceforth "control group")), will be recruited in this study. Half of the participants in the experimental group will be randomly assigned to the EEG-BCI (brain-computer interface) training ("closed-loop") group and will receive training on the BCI task along with muscle and tongue stimulation. The other half of the participants in the experimental group receiving traditional rehab will not receive any kind of FES or tongue stimulation for the first 8-10 weeks of study period and then will start receiving BCI-FES-tongue stimulation rehab therapy.
All participants without UE impairment in Control group 1 will receive 4-6 (minimum 4, up to a maximum of 6) sessions of training on the BCI system and pre- and post MRI and 2 behavioral testing sessions.
Addition of a Control group 2 is consistent with the AHA grants - Twenty four ischemic stroke patients with moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45); no upper extremity injury or conditions that limited use prior to the stroke; and pre-stroke independence with a Modified Rankin Score of 0 or 1), will be recruited in this arm. All participants in this group will receive MR sessions and behavioral testing similar to the Experimental group.
Addition of an Experimental group receiving EEG-BCI-bilateral FES intervention using the recoveriX system: recoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions. Through the EEG-based recoveriX BCI system, the brain receives visual and tactile feedback in real-time, making rehabilitation more effective. A stroke patient imagines a hand movement while receiving visual feedback through a virtual avatar, and tactile feedback through electrical muscle stimulation paired to the patient's imagined movement, with the aim that these patients might regain the volitional ability to grasp following therapy. Unlike the current EEG-BCI-FES intervention that involves stimulation of only the impaired arm, with recoveriX, both arms are simultaneously stimulated during the course of the intervention.
Specific Aims
To determine if functional muscle stimulation of the arms, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery as measured by behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI).
Primary objective
Secondary objective
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group - Immediate BCI Therapy | Experimental | EEG - BCI training (closed loop) |
|
| Experimental Group - Delayed BCI Therapy | Experimental | Scanned and tested 4 times over a 10-week period before EEG-BCI training |
|
| Experimental Group - RecoveriX | Experimental | Recruited from participants who have completed the study intervention |
|
| Control Group 1 | Active Comparator | 48 stroke patients, 48 participants with risk factors for stroke, 48 healthy controls receiving 4-6 training sessions on the EEG-BCI, pre- and post- behavioral testing, and MRI |
|
| Control Group 2 | Active Comparator | 24 Stroke Patients with UE impairment receiving standard FES only therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Electric Stimulation (FES) | Device | FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function. |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test Scores | The Action Research Arm Test (ARAT) is designed for evaluation of upper extremity function. This test consists of sections for Grasp, Grip, Pinch and Gross Movements and comprise a total of 19 tests. Each test is scored 0-3 where 0 is 'no movement' and 3 is 'the movement is performed normally'. Each section is scored separately and the scores added for a total possible range of scores from 0-57 where the higher the score, the complete and efficient the movement. ARAT will be assessed at baseline and end of study (approximately 4 months) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Electroencephalogram (EEG) Response Strength | The change in the strength of the EEG response before and after functional stimulation during left arm imagery with respect to right arm imagery. | 4 months |
| Signal change in functional MRI |
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Inclusion Criteria (Experimental Group):
Inclusion Criteria (Control Group 1)
Stroke patients without UE impairments
Participants with risk factors for stroke
healthy controls
Inclusion Criteria (Control Group 2)
Exclusion Criteria (for all participants):
Exclusion Criteria (for healthy controls)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radiology Studies | Contact | 608-282-8349 | Radstudy@uwhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Vivek Prabhakaran, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53706 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27695404 | Result | Young BM, Stamm JM, Song J, Remsik AB, Nair VA, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Brain-Computer Interface Training after Stroke Affects Patterns of Brain-Behavior Relationships in Corticospinal Motor Fibers. Front Hum Neurosci. 2016 Sep 16;10:457. doi: 10.3389/fnhum.2016.00457. eCollection 2016. | |
| 26157378 |
| Label | URL |
|---|---|
| Publication resulting from this work. | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000783 | Aneurysm |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Behavioral Assessments | Behavioral | These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living. |
|
| Magnetic Resonance Imaging | Other | A functional magnetic resonance image will be collected. |
|
| EEG | Other | EEG electrodes will be attached to the participant's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex. |
|
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| RecoveriX | Other | RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions. |
|
| Delay | Other | 10 week delay before intervention |
|
| BCI-FES | Device |
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To compare the percent signal change in the functional MRI activations before and after functional stimulation.
| 4 months |
| Young BM, Nigogosyan Z, Walton LM, Remsik A, Song J, Nair VA, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Dose-response relationships using brain-computer interface technology impact stroke rehabilitation. Front Hum Neurosci. 2015 Jun 23;9:361. doi: 10.3389/fnhum.2015.00361. eCollection 2015. |
| 25964753 | Result | Song J, Nair VA, Young BM, Walton LM, Nigogosyan Z, Remsik A, Tyler ME, Farrar-Edwards D, Caldera KE, Sattin JA, Williams JC, Prabhakaran V. DTI measures track and predict motor function outcomes in stroke rehabilitation utilizing BCI technology. Front Hum Neurosci. 2015 Apr 27;9:195. doi: 10.3389/fnhum.2015.00195. eCollection 2015. |
| 25120466 | Result | Song J, Young BM, Nigogosyan Z, Walton LM, Nair VA, Grogan SW, Tyler ME, Farrar-Edwards D, Caldera KE, Sattin JA, Williams JC, Prabhakaran V. Characterizing relationships of DTI, fMRI, and motor recovery in stroke rehabilitation utilizing brain-computer interface technology. Front Neuroeng. 2014 Jul 29;7:31. doi: 10.3389/fneng.2014.00031. eCollection 2014. |
| 25009491 | Result | Young BM, Nigogosyan Z, Nair VA, Walton LM, Song J, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Case report: post-stroke interventional BCI rehabilitation in an individual with preexisting sensorineural disability. Front Neuroeng. 2014 Jun 24;7:18. doi: 10.3389/fneng.2014.00018. eCollection 2014. |
| 30899211 | Derived | Remsik AB, Williams L Jr, Gjini K, Dodd K, Thoma J, Jacobson T, Walczak M, McMillan M, Rajan S, Young BM, Nigogosyan Z, Advani H, Mohanty R, Tellapragada N, Allen J, Mazrooyisebdani M, Walton LM, van Kan PLE, Kang TJ, Sattin JA, Nair VA, Edwards DF, Williams JC, Prabhakaran V. Ipsilesional Mu Rhythm Desynchronization and Changes in Motor Behavior Following Post Stroke BCI Intervention for Motor Rehabilitation. Front Neurosci. 2019 Mar 6;13:53. doi: 10.3389/fnins.2019.00053. eCollection 2019. |
| 30467461 | Derived | Remsik AB, Dodd K, Williams L Jr, Thoma J, Jacobson T, Allen JD, Advani H, Mohanty R, McMillan M, Rajan S, Walczak M, Young BM, Nigogosyan Z, Rivera CA, Mazrooyisebdani M, Tellapragada N, Walton LM, Gjini K, van Kan PLE, Kang TJ, Sattin JA, Nair VA, Edwards DF, Williams JC, Prabhakaran V. Behavioral Outcomes Following Brain-Computer Interface Intervention for Upper Extremity Rehabilitation in Stroke: A Randomized Controlled Trial. Front Neurosci. 2018 Nov 8;12:752. doi: 10.3389/fnins.2018.00752. eCollection 2018. |
| Publication resulting from this work. | View source |
| Publication resulting from this work. | View source |
| Publication resulting from this work. | View source |
| Publication resulting from this work. | View source |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |