A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training

NCT02132520 | Completed Results

• 2 other identifiers: 1306M36401CBET-1264562
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the combination of low frequency repetitive transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface (BCI) training is effective for enhancing motor recovery after stroke. The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rTMS and BCI training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.

Conditions

Hemiparesis; Stroke

Keywords

Hemiparesis; Stroke; Rehabilitation; Transcranial Magnetic Stimulation, Repetitive; Electroencephalography; Functional Neuroimaging; Brain-Computer Interface

Outcome Measures

Primary Outcomes (1)

• Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI

  The MRI and functional MRI will evaluate the extent to which cortical areas are recruited both during rest and during movement related tasks. This is quantified by a laterality index, calculated as the ratio of activations of ipsi- and contra-lesional precentral gyri during a paretic hand tracking task. A LI of -1 corresponds to entirely contralesional activation, while a value of +1 corresponds to entirely ipsilesional activation.

  Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)

Secondary Outcomes (3)

• Changes in Hand Motor Function as Measured by the Box and Block Test

  Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)

• Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test

  Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)

• Changes in Inter-hemispheric Inhibition

  Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)

Other Outcomes (2)

• Subject Report of Symptoms

  within 12 weeks of participation

• Changes in the Resting Motor Threshold

  Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)

Study Arms (3)

Control

NO INTERVENTION

Subjects receiving standard-of-care physical therapy only.

Sham rTMS + Real BCI Training

SHAM COMPARATOR

Subjects will receive sham rTMS followed by real BCI training.

Device: rTMS; Behavioral: BCI Training

Real rTMS + Real BCI Training

ACTIVE COMPARATOR

Subjects will receive real rTMS followed by real BCI training.

Device: rTMS; Behavioral: BCI Training

Interventions

rTMS DEVICE

Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.

Real rTMS + Real BCI Training; Sham rTMS + Real BCI Training

BCI Training BEHAVIORAL

BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.

Real rTMS + Real BCI Training; Sham rTMS + Real BCI Training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Cortical or subcortical stroke with isolated unilateral motor paresis
• At least 3 months but no greater than 12 months post stroke and in stable conditions as judged by patient's physician
• Impaired hand function compared to nonparetic side but at least 10 degrees of active finger extension
• Able to ambulate at least 50 feet with minimal stand-by assistance
• Upper Extremity Fugl Meyer (Fugl-Meyer et al., 1975) score of greater than or equal to 20 out of 66
• Beck Depression Inventory (Beck et al., 1961) less than or equal to 19 out of 63
• Mini-mental State Examination score (Folstein et al., 1975) greater than or equal to 24 out of 30
• Must have an ipsilesional motor-evoked potential (MEP) in response to TMS
• Must be stable outpatients currently undergoing rehabilitation consistent with the current standards of care
• Must be able to communicate clearly in English
• Must be able to provide consent in writing.

You may not qualify if:

• Personal history of epilepsy or seizures within the past 2 years
• Previous surgical procedure to the spinal cord
• Any MRI incompatible devices
• Pregnancy
• Claustrophobia
• Breathing disorder
• Hearing problems or ringing in the ears
• Bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
• Cognitive deficits, other non-motor neurological impairment, bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Clinical and Translational Science Institute

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Paresis; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Bin He
• Organization: University of Minnesota

binhe@umn.edu

612-626-1115

Study Officials

• Bin He, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: May 7, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 1, 2019
• Results First Posted: January 3, 2019

Record last verified: 2019-10

Locations

US (1)