Treatment of Chronic Stroke With IpsiHand
A Brain Computer Interface and Brain-Controlled Stroke Rehabilitation Method Utilizing Electroencephalography in Hemiparetic and Hemiplegic Stroke Patients to Achieve Thought Control of Machines and a Better Understanding of Brain Function
1 other identifier
interventional
23
1 country
1
Brief Summary
The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2012
Typical duration 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2015
CompletedResults Posted
Study results publicly available
September 17, 2018
CompletedSeptember 17, 2018
September 1, 2018
3.3 years
August 22, 2015
February 20, 2018
September 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Action Research Arm Test (ARAT) Score
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation (Platz, Pinkowski, Kim, di Bella, \& Johnson, 2005). The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3\) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1\) Performs test partially 0) Can perform no part of test The maximum score achievable on this measure is 57 points.
Baseline and 12 weeks
Secondary Outcomes (1)
Canadian Occupational Performance Measure (COPM)
Baseline and 12 weeks
Study Arms (1)
IpsiHand
EXPERIMENTALIpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.
Interventions
Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity.
Eligibility Criteria
You may qualify if:
- months post stroke
- Modified Ashworth Scale of 1+ or less of elbow flexion in the affected upper extremity
- Short Blessed Test Score of 8 or less
- Unstructured Mesulam with 2 or less omissions
You may not qualify if:
- Dementia
- Severe spasticity in affected upper extremity
- Unilateral Visual Inattention (neglect)
- Contracture(s) in the affected upper extremity
- Botox injections administered within 9 months
- Aphasia which limits effective communication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Bundy DT, Souders L, Baranyai K, Leonard L, Schalk G, Coker R, Moran DW, Huskey T, Leuthardt EC. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke. 2017 Jul;48(7):1908-1915. doi: 10.1161/STROKEAHA.116.016304. Epub 2017 May 26.
PMID: 28550098DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Thy Huskey
- Organization
- Washington University School of Medicine - Department of Neurology
Study Officials
- PRINCIPAL INVESTIGATOR
Thy Huskey, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2015
First Posted
September 17, 2015
Study Start
August 1, 2012
Primary Completion
November 30, 2015
Study Completion
November 30, 2015
Last Updated
September 17, 2018
Results First Posted
September 17, 2018
Record last verified: 2018-09