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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02132520
First received: April 8, 2014
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Hemiparesis
Stroke
Device: rTMS
Behavioral: BCI Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined Repetitive Transcranial Magnetic Stimulation and Brain-Computer Interface Training

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in Hand Motor Function over 12 weeks as measured by the Jebsen Taylor Hand Test [ Time Frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-Up (12 weeks) ] [ Designated as safety issue: No ]
    The Jebsen Taylor Hand Test will be administered for the paretic hand and scores recorded for page turning, small object manipulation, feeding, stacking, light can manipulation, and heavy can manipulation.


Secondary Outcome Measures:
  • Changes in Hand Motor Function over 12 weeks as measured by the Box and Block Test [ Time Frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) ] [ Designated as safety issue: No ]
    Performance on the box and block test with the paretic hand.

  • Changes in Hand Motor Function over 12 weeks as measured by the Finger Tracking Test [ Time Frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) ] [ Designated as safety issue: No ]
    The finger tracking test will evaluate the subject's ability to track an oscillating wave with either their paretic or non-paretic finger.

  • Changes in the Resting Motor Threshold over 12 weeks [ Time Frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) ] [ Designated as safety issue: No ]
    The resting motor threshold is a measure of cortical excitability, and will be recorded for both the stroke and non-stroke hemispheres.

  • Changes in Inter-hemispheric Inhibition over 12 weeks [ Time Frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) ] [ Designated as safety issue: No ]
    Inter-hemispheric Inhibition will be evaluated using paired-pulse TMS both for the stroke hemisphere to non-stroke hemisphere direction as well as for the non-stroke hemisphere to the stroke hemisphere direction.

  • Changes in the NIH Stroke Scale over 12 weeks [ Time Frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks), Follow-up (12 weeks) ] [ Designated as safety issue: Yes ]
    The NIH Stroke Scale is a quantitative measure of stroke-related neurological deficit.

  • Subject Report of Symptoms [ Time Frame: within 12 weeks of participation ] [ Designated as safety issue: Yes ]
    The subject report of symptoms assesses whether subject experience any adverse effects as a result of participation in the study.


Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Subjects receiving standard-of-care physical therapy only.
Sham Comparator: Sham rTMS + Real BCI Training
Subjects will receive sham rTMS followed by real BCI training.
Device: rTMS
Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
Behavioral: BCI Training
BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
Active Comparator: Real rTMS + Real BCI Training
Subjects will receive real rTMS followed by real BCI training.
Device: rTMS
Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
Behavioral: BCI Training
BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.

Detailed Description:

The goal of the present study is to develop and evaluate a brain based approach to improve motor recovery after stroke, by combining rTMS and BCI training. Treatments will consist of low frequency rTMS applied to the contralesional hemisphere, followed by BCI training to encourage activity within the lesioned hemisphere. The primary objective of this study is to test the main hypothesis above in a stroke patient population. Subjects will also undergo a period of BCI only treatments after completion of the combined rTMS and BCI portion.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-70 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02132520

Locations
United States, Minnesota
Clinical and Translational Science Institute
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Bin He, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02132520     History of Changes
Other Study ID Numbers: NSF CBET-1264562
Study First Received: April 8, 2014
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Hemiparesis
Stroke
Rehabilitation
Transcranial Magnetic Stimulation, Repetitive
Electroencephalography
Functional Neuroimaging
Brain-Computer Interface

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

ClinicalTrials.gov processed this record on August 28, 2014