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Trial record 16 of 22 for:    BCI | Stroke

Treatment of Chronic Stroke With IpsiHand

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ClinicalTrials.gov Identifier: NCT02552368
Recruitment Status : Completed
First Posted : September 17, 2015
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Stroke Device: IpsiHand Device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2012
Actual Primary Completion Date : November 30, 2015
Actual Study Completion Date : November 30, 2015

Arm Intervention/treatment
Experimental: IpsiHand
IpsiHand 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.
Device: IpsiHand Device
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.




Primary Outcome Measures :
  1. Change in Action Research Arm Test (ARAT) Score [ Time Frame: Baseline and 12 weeks ]

    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.



Secondary Outcome Measures :
  1. Canadian Occupational Performance Measure (COPM) [ Time Frame: Baseline and 12 weeks ]
    The COPM is an evidence-based outcome measure designed to capture a client's self-perception of performance in 5 patient-identified tasks over time. Patients identified 5 functional activities that they wanted to perform more independently or with greater ease. COPM measurements consisted of a semi-structured interview in which patients rated their performance & satisfaction with each activity on an ordinal scale from 1 to 10. A performance score of 1 indicated they are unable to perform identified task, & a score of 10 indicates they are able to complete the functional task as easy as prior to stroke. A satisfaction score of 1 indicated they were not satisfied at all to 10 indicating they are extremely satisfied with how they complete the identified functional task. Patients would rate (5) functional tasks for their performance and satisfaction. Scores were averaged between the scores from the 5 functional activities.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552368


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Thy Huskey, MD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02552368     History of Changes
Other Study ID Numbers: 201021771
First Posted: September 17, 2015    Key Record Dates
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018
Last Verified: September 2018

Keywords provided by Washington University School of Medicine:
Stroke Rehabilitation
BCI
Stroke
Upper Extremity Rehabilitation
paresis
hemiparesis

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases