Washington University in Saint Louis
St Louis, Missouri, 63110, United States
NCT Number: NCT05965713
The goal of this study is to define the efficacy of fully remote home-based BCI therapy in chronic hemiparetic subcortical stroke patients. A randomized controlled study using the integrated remote BCI system will be tested against standard exercise therapy to determine the efficacy of motor improvement in chronic stroke patients with an upper extremity hemiparesis. Specifically, the integrated BCI system will include 1) the remote screening and motor assessment system for the upper extremity and 2) the BCI-controlled robotic hand exoskeleton (i.e. IpsiHand).
Looking for future studies?
Notify Me18 year–85 year
All sexes
Interventional
Not applicable
St Louis, Missouri, 63110, United States
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 is to develop a system that allows for enhanced functional capability and works consistently over a long-term basis and is accessible remotely no matter location or access to healthcare. In developing a new rehabilitation method, the researchers hope to create a system that allows for closed loop feedback through a robotic hand orthosis on the motor impaired side of stroke patients in response to intended movements of the muscles. The method, if successful, would represent an ideal, non-invasive method of promoting motor learning and recovery in stroke survivors. The ability to operate robotic hand orthosis using electrical signals of the brain is rapidly leaving the realm of science fiction and becoming a realistic goal of the clinical community. The current advances in BCI controlled neuroprosthetics could have immeasurable influence on adult patients with severe motor impairments from stroke. Even further on the horizon the insights developed from such work could substantively alter the way all stroke patients are treated and rehabilitated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline and at 12 weeks completion of IpsiHand use.
Subjects will receive a customized standard of care home exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks.
Time frame: Assessed at baseline visit and at completion of study
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time frame: Baseline, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week completion assessment
Shortened and validated digitized assessment tool derived from the Fugl-Meyer Long form developed by Neurolutions of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Embedded into study software. Lowest score 0, highest score 66.
Time frame: Baseline and 12 week completion assessment
Evaluation of two and three point pinch strength via dynamometry; lowest score= 0lbs, highest score =150lbs
Time frame: Baseline and 12 week completion assessment
Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs
Time frame: Baseline and 12 week completion assessment
Evaluation of motor strength on the shoulder, elbow and pinch. Scored on a 0-5 scale. 0 being totally absent muscle strength and range of motion, 5 bring full strength and range of motion of limb.
Time frame: Baseline and 12 week completion assessment
Assessment of language function for classification of aphasia following a stoke.
Time frame: Baseline and 12 week completion assessment
Assessment functional mobility and fall risk
Time frame: Baseline and 12 week completion assessment
Assessment functional mobility, speed of mobility and fall risk
Time frame: Baseline and 12 week completion assessment
Assessment to evaluate upper extremity function in activities of daily living
Time frame: Baseline and 12 week completion assessment
Assessment of general cognitive function specifically assesses working memory, visual processing, visuospatial skills, selective and divided attention.
Time frame: Baseline and 12 week completion assessment
A widely used assessment tool for measuring the degree of disability or dependence in people who have experienced stroke or other neurological conditions. The sale ranges from 0 (no symptoms) to 6 (death), and is commonly used as a primary outcome measure in stroke clinical trials.
Time frame: Baseline and 12 week completion assessment
A widely used assessment tool for self reporting of depression. This assessment is scored from 0-27.
0-4: Minimal or no depression. 5-9: Mild depression. 10-14: Moderate depression. 15-19: Moderately severe depression. 20-27: Severe depression.
Time frame: Baseline and 12 week completion assessment
Widely used questionnaire designed to assess the level of burden experienced by caregivers
Time frame: Baseline and 12 week completion assessment
Assessment tool that measures a person's functional independence in activities of daily living and self-care
Neurolutions, Inc.
Industry
IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06311526
Brain Diseases, Cardiovascular Diseases
Milan, MI, Italy
View Trial DetailsNCT03080454
Brain Diseases, Cardiovascular Diseases
Manhasset, New York, United States
View Trial DetailsNCT01573585
Brain Diseases, Cardiovascular Diseases
North Vancouver, British Columbia, Canada
View Trial DetailsNCT07002463
Brain Diseases, Cardiovascular Diseases
Wroclaw, Poland
View Trial Details