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Trial record 11 of 22 for:    BCI | Stroke

Chronic Stroke Rehabilitation With Contralesional Brain-Computer Interface

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ClinicalTrials.gov Identifier: NCT03611855
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Neurolutions, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

The purpose of this research study is to show that a computer can analyze brain waves and that those brain waves can be used to control an external device. This study will also show whether passive movement of the affected hand as a result of brain-based control can cause rehabilitation from the effects of a stroke. Additionally, this study will show how rehabilitation with a brain-controlled device may affect the function and organization of the brain.

Stroke is the most common neurological disorder in the US with 795,000 strokes per year (Lloyd-Jones et al. 2009). Of survivors, 15-30% are permanently disabled and 20% require institutional care (Mackay et al. 2004; Lloyd-Jones et al. 2009). In survivors over age 65, 50% had hemiparesis, 30% were unable to walk without assistance, and 26% received institutional care six months post stroke (Lloyd-Jones et al. 2009). These deficits are significant, as recovery is completed after three months (Duncan et al. 1992; Jorgensen et al. 1995). This large patient population with decreased quality of life fuels the need to develop novel methods for improving functional rehabilitation. We propose that signals from the unaffected hemisphere can be used to develop a novel Brain-Computer interface (BCI) system that can facilitate functional improvement or recovery. This can be accomplished by using signals recorded from the brain as a control signal for a robotic hand orthotic to improve motor function, or by strengthening functional pathways through neural plasticity. Neural activity from the unaffected hemisphere to the affected hemiparetic limb would provide a BCI control in stroke survivors lesions that prevent perilesional mechanisms of motor recovery. The development of BCI systems for functional recovery in the affected limb in stroke survivors will be significant because they will provide a path for improving quality of life for chronic stroke survivors who would otherwise have permanent loss of function. Initially, the study will serve to determine the feasibility of using EEG signals from the non-lesioned hemisphere to control a robotic hand orthotic. The study will then determine if a brain-computer interface system can be used to impact rehabilitation, and how it may impact brain function. The system consists of a research approved EEG headset, the robotic hand orthotic, and a commercial tablet. The orthotic will be made, configured, and maintained by Neurolutions. Each participant will complete as many training sessions as the participant requires, during which a visual cue will be shown to the participant to vividly imagine moving their impaired upper extremity to control the opening and closing of the orthotic. Participants may also be asked to complete brain scans using magnetic resonance imaging (MRI).


Condition or disease Intervention/treatment Phase
Chronic Stroke Hemiparesis Device: BCI Rehabilitation Other: Range of Motion Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Study Population in 2 groups: Group 1 participates in MRI before treatment, at crossover, and at study completion. Group 1 participants either receive rehabilitation via BCI device then cross over to a standard range-of-motion program, or start with a range-of-motion program then crossover to receive BCI rehabilitation. A balanced number of participants will be assigned to the different orders within Group 1.

Group 2 receives no MRI, and is not assigned a range-of-motion program. Thus, Group 2 only receives BCI rehabilitation and does not cross over.

Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Neural Mechanisms of a Contralesionally-Driven Brain-Computer Interface for Motor Rehabilitation of Chronic Stroke
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: BCI Rehabilitation
Patients trained on use of BCI-controlled orthotic device are given a device for home use. Patients are asked to use the device an hour per day, 5 days per week, for 12 weeks. During device use, patients are instructed via pre-programmed instructions on a tablet paired with the device to either rest or vividly imagine moving their affected hand. The device receives signals from a scalp electrodes within a headset the patient dons prior to use. The device interprets these signals and closes the patient's hand during a successful rest trial, and opens the patient's hand during a successful move trial.
Device: BCI Rehabilitation
Patients use electroencephalography (EEG) signals to control a motorized glove worn on their affected hand. The glove moves the patient's hand according to the type of signal detected (Rest vs Motor Imagery).
Other Name: Ipsihand

Active Comparator: Range of Motion Therapy
Active and Passive Range-of-Motion (AROM, PROM) therapy strategies are commonly prescribed by physical therapists for at-home post-stroke motor deficit rehabilitation that can be performed independently. Patients practice movement with joints and limbs affected by the stroke, either by using the unaffected limb (or the assistance of a caretaker) to stretch the affected limb (PROM) or by actively moving the affected limb (AROM). Patients are asked to perform this therapy one hour per day, 5 days per week, for 12 weeks.
Other: Range of Motion Therapy
Patients repeatedly move or stretch the joints and muscles of their affected limb, either by actively moving the limb or assisting the limb with no active motion.
Other Names:
  • Active Range of Motion
  • Passive Range of Motion




Primary Outcome Measures :
  1. Change in Fugl-Meyer (Upper Extremity) Assessment Score [ Time Frame: 24 weeks from baseline ]
    The primary outcome for determining motor function improvement is the change over time in the upper extremity portion of the Fugl-Meyer Assessment (FMA). The difference between FMA scores pre- and post-BCI rehab, subtracted by the change in FMA during range-of-motion therapy, will be used to quantify change in motor function.


Secondary Outcome Measures :
  1. Change in Corticospinal Tract Integrity [ Time Frame: 24 weeks from baseline ]
    Difference in fractional anisotropy (FA) of the corticospinal tract during BCI rehabilitation subtracted by change in FA of the corticospinal tract during range-of-motion therapy

  2. Change in Interhemispheric Somatomotor Connectivity [ Time Frame: 24 weeks from baseline ]
    Change in average resting state connectivity between left and right somatomotor brain regions during BCI rehabilitation subtracted by change in average resting state connectivity between left and right somatomotor brain regions during range-of-motion therapy

  3. Change in Motricity Index [ Time Frame: 24 weeks from baseline ]
    Change in spasticity measured with Motricity Index during BCI rehabilitation subtracted by change in spasticity measured with Motricity Index during range-of-motion therapy

  4. Change in Grasp Strength [ Time Frame: 24 weeks from baseline ]
    Change in grasp strength during BCI rehabilitation subtracted by change in grasp strength during range-of-motion therapy

  5. Change in Arm Motor Ability Test Score [ Time Frame: 24 weeks from baseline ]
    Change in ability to perform activities of daily living (ADLs) as measured by the Arm Motor Ability Test (AMAT) score during BCI rehabilitation subtracted by change in ability to perform ADLs as measured by AMAT score during range-of-motion therapy



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic stroke survivors at least 6 months post-stroke with moderate functional impairment of the right or left upper extremity as evidenced by motor function screening assessments
  • If receiving Botox injections in the upper extremity for spasticity management, device use must be initiated within 15 days of a Botox injection

Exclusion Criteria:

  • Cognitive impairment as indicated by a Short-Blessed Test score of 8 or more
  • Joint contractures in the affected wrist or digits
  • Receptive aphasia or inability to follow written instructions as indicated by a score of 6 or less on the MS Aphasia Screening Test
  • High spasticity as indicated by a Modified Ashworth Scale of elbow flexion of 3 or greater
  • Unilateral visual inattention (i.e. "neglect") as determined by unilaterally omitting 3 or more targets on the Mesulam Cancellation Test
  • Patients contraindicated for MRI imaging due to safety concerns will be excluded from Group 1, but will have the option to be assigned to Group 2 should they meet other Inclusion and Exclusion criteria.
  • Inability to produce EEG signals sufficient for device control following EEG screening

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): NCT03611855


Contacts
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Contact: Theresa Notestine, DPT (314) 658-3842 tnotestine@wustl.edu
Contact: Alexandre Carter, MD, PhD (314) 362-7620 alexandre.carter@wustl.edu

Locations
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United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Theresa Notestine, DPT    314-658-3842    tnotestine@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Neurolutions, Inc.
Investigators
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Principal Investigator: Eric Leuthardt, MD Washington University School of Medicine

Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03611855     History of Changes
Other Study ID Numbers: 201701021
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized participant demographics, EEG data, and neuroimaging data will be provided with other researchers by request starting 6 months after publication of primary findings.
Supporting Materials: Study Protocol
Analytic Code
Time Frame: Data becomes available 6 months after publication of primary findings. Data will be available indefinitely.
Access Criteria: Data will be provided via secure transfer service upon request members of respected research institutions, be they academic, government, or otherwise.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
Brain-Computer Interface
Motor Rehabilitation
Electroencephalography
Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms