Clinical trial NCT02552368: Treatment of Chronic Stroke With IpsiHand
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke Rehabilitation
BCI
Stroke
Upper Extremity Rehabilitation
paresis
hemiparesis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study will be carried out in two phases designed to achieve the objectives described above. The first phase will determine the feasibility of recording ipsilateral (contralesional) motor commands and use the signals to control a computer. This phase will involve recording EEG signals during the performance of real and imagined motor movements of both the impaired and non-impaired hand in stroke survivors. After recording the signals and analyzing the data, the signals will be used to try to control a cursor on a computer screen or a robotic hand. The second phase of the study will determine if the BCI system can be used to impact rehabilitation. Motor commands would be performed as in phase 1 to determine the accompanying EEG signals. The EEG signals would then be used to control stimulation of the impaired limb. Rehabilitation would be assessed by examining changes in commonly used functional motor scores.

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.

Eligibility criteria: Inclusion Criteria:

* 6 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Action Research Arm Test (ARAT) Score
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Thy Huskey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.