A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
5 other identifiers
interventional
288
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jun 2010
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 6, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
May 16, 2025
May 1, 2025
16 years
March 6, 2014
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Change in Electroencephalogram (EEG) Response Strength
4 months
Signal change in functional MRI
4 months
Study Arms (5)
Experimental Group - Immediate BCI Therapy
EXPERIMENTALEEG - BCI training (closed loop)
Experimental Group - Delayed BCI Therapy
EXPERIMENTALScanned and tested 4 times over a 10-week period before EEG-BCI training
Experimental Group - RecoveriX
EXPERIMENTALRecruited from participants who have completed the study intervention
Control Group 1
ACTIVE COMPARATOR48 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 COMPARATOR24 Stroke Patients with UE impairment receiving standard FES only therapy
Interventions
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.
These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
A functional magnetic resonance image will be collected.
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.
RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- American Heart Associationcollaborator
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53706, United States
Related Publications (7)
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.
PMID: 27695404RESULTYoung 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.
PMID: 26157378RESULTSong 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.
PMID: 25964753RESULTSong 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.
PMID: 25120466RESULTYoung 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.
PMID: 25009491RESULTRemsik 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.
PMID: 30899211DERIVEDRemsik 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.
PMID: 30467461DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vivek Prabhakaran, MD, PhD
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2014
First Posted
March 27, 2014
Study Start
June 1, 2010
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
May 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share