Chronic Stroke Rehabilitation With Contralesional Brain-Computer Interface

NCT03611855 | Terminated

• 1 other identifier: 201701021
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Stroke; Hemiparesis

Keywords

Brain-Computer Interface; Motor Rehabilitation; Electroencephalography; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

BCI Rehabilitation

EXPERIMENTAL

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

Range of Motion Therapy

ACTIVE COMPARATOR

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

Interventions

BCI Rehabilitation DEVICE

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).

Also known as: Ipsihand

BCI Rehabilitation

Range of Motion Therapy OTHER

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.

Also known as: Active Range of Motion, Passive Range of Motion

Range of Motion Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 Mississippi 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
• Inability to produce EEG signals sufficient for device control following EEG screening

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Neurolutions, Inc.: collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• 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.

  PMID: 1636182 BACKGROUND

• 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.

  PMID: 19075105 BACKGROUND

• 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.

  PMID: 11387487 BACKGROUND

• 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.

  PMID: 7741609 BACKGROUND

• 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.

  PMID: 39345118 DERIVED

MeSH Terms

Conditions

Paresis

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eric Leuthardt, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: April 26, 2018
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)