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The Neural Mechanisms of a Contralesionally-Driven Brain-Computer Interface for Motor Rehabilitation of Chronic Stroke
Sponsor study identifier
interventional
56
1 country
1
Study Start
April 26, 2018
Actual (reported)Primary Completion
March 18, 2020
Actual (reported)Study Completion
March 18, 2020
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 18, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 26, 2018
Actual (reported)July 26, 2018
Actual (reported)August 2, 2018
Actual (reported)March 18, 2020
Actual (reported)March 18, 2020
Actual (reported)Change in Fugl-Meyer (Upper Extremity) Assessment Score
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.
24 weeks from baseline
Change in Corticospinal Tract Integrity
24 weeks from baseline
Change in Interhemispheric Somatomotor Connectivity
24 weeks from baseline
Change in Motricity Index
24 weeks from baseline
Change in Grasp Strength
24 weeks from baseline
Change in Arm Motor Ability Test Score
24 weeks from baseline
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.
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.
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).
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.
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Duncan PW, Goldstein LB, Matchar D, Divine GW, Feussner J. Measurement of motor recovery after stroke. Outcome assessment and sample size requirements. Stroke. 1992 Aug;23(8):1084-9. doi: 10.1161/01.str.23.8.1084.
Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. No abstract available.
Eric Leuthardt, MD
Washington University School of Medicine
56 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2018
First Posted
August 2, 2018
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lawrence ES, Coshall C, Dundas R, Stewart J, Rudd AG, Howard R, Wolfe CD. Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke. 2001 Jun;32(6):1279-84. doi: 10.1161/01.str.32.6.1279.
Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):406-12. doi: 10.1016/s0003-9993(95)80568-0.
Rustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Rehabilitation in Chronic Stroke. Neurorehabil Neural Repair. 2025 Jan;39(1):74-86. doi: 10.1177/15459683241287731. Epub 2024 Sep 30.
Study Start
April 26, 2018
Actual (reported)Primary Completion
March 18, 2020
Actual (reported)Study Completion
March 18, 2020
Actual (reported)Last Updated
May 19, 2021
Record last verified: 2021-05
Anonymized participant demographics, EEG data, and neuroimaging data will be provided with other researchers by request starting 6 months after publication of primary findings.
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Source: ClinicalTrials.gov.
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