StrokeNCT02098265
A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
A study testing Functional Electric Stimulation (FES), Behavioral Assessments and Magnetic Resonance Imaging in people with Stroke, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Functional Electric Stimulation (FES), Behavioral Assessments and Magnetic Resonance Imaging
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke patients with persistent upper extremity (UE) deficits
- Stroke patients without UE impairments
- Participants with risk factors for stroke
- healthy controls
- No known neurologic, psychiatric or developmental disability
- Stroke patients with persistent upper extremity (UE) deficits
Show all 9Show fewer
- 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
- Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention.
Who cannot join
- Allergic to electrode gel, surgical tape and metals
- Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study
- Women who are pregnant or may become pregnant during the course of the study will be excluded
- Participants with contraindications for MRI will be offered the opportunity to participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing)
- Contraindications for MRI
- Allergic to electrode gel, surgical tape, and metals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53706
Veena Nair, PhD, 608-265-5269, vnair@uwhealth.org
About this study
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.
Read the detailed description
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
- To examine the effect of EEG guided functional muscle stimulation on improvement in upper extremity function
Secondary objective
- To examine plasticity changes as measured by EEG/fMRI measures before and after EEG guided functional muscle stimulation.
- Conditions
- Stroke
- Being tested
- Functional Electric Stimulation (FES), Behavioral Assessments, Magnetic Resonance Imaging, EEG, RecoveriX
- Keywords
- aneurysm, transient ischemic attack
- Medical subject headings
- Stroke, Aneurysm, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Behavioral AssessmentsBehavioural
These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
Magnetic Resonance ImagingOther
A functional magnetic resonance image will be collected.
EEGOther
Also called Electroencephalography
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.
RecoveriXOther
RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.
DelayOther
10 week delay before intervention
BCI-FESDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group - Immediate BCI Therapy | Experimental | EEG - BCI training (closed loop) Receives: Behavioral: Behavioral Assessments; Other: Magnetic Resonance Imaging; Other: EEG; Device: BCI-FES |
| Experimental Group - Delayed BCI Therapy | Experimental | Scanned and tested 4 times over a 10-week period before EEG-BCI training Receives: Behavioral: Behavioral Assessments; Other: Magnetic Resonance Imaging; Other: EEG; Other: Delay; Device: BCI-FES |
| Experimental Group - RecoveriX | Experimental | Recruited from participants who have completed the study intervention Receives: Other: RecoveriX |
| 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 Receives: Behavioral: Behavioral Assessments; Other: Magnetic Resonance Imaging; Other: EEG; Device: BCI-FES |
| Control Group 2 | Active comparator | 24 Stroke Patients with UE impairment receiving standard FES only therapy Receives: Device: Functional Electric Stimulation (FES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 months
Secondary outcomes (2)
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.
Measured: 4 months
Signal change in functional MRI
To compare the percent signal change in the functional MRI activations before and after functional stimulation.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startJun 2010
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Vivek Prabhakaran, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098265
- Sponsor's protocol ID
- 2015-0469
- Other IDs
- 15GRNT25780033, A539300, SMPH/RADIOLOGY, Protocol Version 2/19/26
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2014
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27695404Young 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.
PubMed 26157378Song 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.
PubMed 25964753Song 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.
PubMed 25120466Young 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.
PubMed 25009491Remsik 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.
PubMed 30899211Remsik 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.
PubMed 30467461
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
- ClinicalTrials.gov ID
- NCT02098265
- Acronym / sponsor ID
- 2015-0469
- Conditions
- Stroke
- Keywords
- aneurysm, transient ischemic attack
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jun 2010 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- To examine the effect of EEG guided functional muscle stimulation on improvement in upper extremity function
Secondary objective
- To examine plasticity changes as measured by EEG/fMRI measures before and after EEG guided functional muscle stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - Immediate BCI Therapy | Experimental | Behavioral: Behavioral Assessments, Other: Magnetic Resonance Imaging, Other: EEG, Device: BCI-FESEEG - BCI training (closed loop) |
| Experimental Group - Delayed BCI Therapy | Experimental | Behavioral: Behavioral Assessments, Other: Magnetic Resonance Imaging, Other: EEG, Other: Delay, Device: BCI-FESScanned and tested 4 times over a 10-week period before EEG-BCI training |
| Experimental Group - RecoveriX | Experimental | Other: RecoveriXRecruited from participants who have completed the study intervention |
| Control Group 1 | Active comparator | Behavioral: Behavioral Assessments, Other: Magnetic Resonance Imaging, Other: EEG, Device: BCI-FES48 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 | Device: Functional Electric Stimulation (FES)24 Stroke Patients with UE impairment receiving standard FES only therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stroke patients with persistent upper extremity (UE) deficits
- Stroke patients without UE impairments
- Participants with risk factors for stroke
- healthy controls
- Stroke patients with persistent upper extremity (UE) deficits
Key exclusion criteria (6 listed)
- Allergic to electrode gel, surgical tape and metals
- Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study
- Women who are pregnant or may become pregnant during the course of the study will be excluded
- Participants with contraindications for MRI will be offered the opportunity to participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing)
- Contraindications for MRI
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 |
|---|---|---|
| Functional Electric Stimulation (FES)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. | Device | Control Group 2 |
| Behavioral AssessmentsThese assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living. | Behavioural | Control Group 1, Experimental Group - Delayed BCI Therapy, Experimental Group - Immediate BCI Therapy |
| Magnetic Resonance ImagingA functional magnetic resonance image will be collected. | Other | Control Group 1, Experimental Group - Delayed BCI Therapy, Experimental Group - Immediate BCI Therapy |
| EEGAlso: ElectroencephalographyEEG 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. | Other | Control Group 1, Experimental Group - Delayed BCI Therapy, Experimental Group - Immediate BCI Therapy |
| RecoveriXRecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions. | Other | Experimental Group - RecoveriX |
| Delay10 week delay before intervention | Other | Experimental Group - Delayed BCI Therapy |
| BCI-FES | Device | Control Group 1, Experimental Group - Delayed BCI Therapy, Experimental Group - Immediate BCI Therapy |
Primary outcome
Action Research Arm Test Scores
Time frame: 4 months
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)
2 secondary outcomes
Change in Electroencephalogram (EEG) Response Strength
Time frame: 4 months
Signal change in functional MRI
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Results publication: PubMed 27695404Young 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.
- Results publication: PubMed 26157378Young 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.
- Results publication: PubMed 25964753Song 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.
- Results publication: PubMed 25120466Song 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.
- Results publication: PubMed 25009491Young 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.
- Derived from this study: PubMed 30899211Remsik 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.
- Derived from this study: PubMed 30467461Remsik 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.Link provided by the sponsor.
- Publication resulting from this work.Link provided by the sponsor.
- Publication resulting from this work.Link provided by the sponsor.
- Publication resulting from this work.Link provided by the sponsor.
- Publication resulting from this work.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Vivek Prabhakaran, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electric Stimulation (FES), Behavioral Assessments and Magnetic Resonance Imaging in people with Stroke, run by University of Wisconsin, Madison at 1 site in United States.
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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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 States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radiology Studies (608-282-8349, Radstudy@uwhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test Scores (time frame: 4 months). 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 NCT02098265, which also lists 7 linked publications.
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 17 Sep 2026.