Back to resultsA Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
Primary Purpose
Hemiparesis, Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS
BCI Training
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring Hemiparesis, Stroke, Rehabilitation, Transcranial Magnetic Stimulation, Repetitive, Electroencephalography, Functional Neuroimaging, Brain-Computer Interface
Eligibility 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
Sites / Locations
- Clinical and Translational Science Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Sham Comparator
Active Comparator
Arm Label
Control
Sham rTMS + Real BCI Training
Real rTMS + Real BCI Training
Arm Description
Subjects receiving standard-of-care physical therapy only.
Subjects will receive sham rTMS followed by real BCI training.
Subjects will receive real rTMS followed by real BCI training.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in Hand Motor Function as Measured by the Box and Block Test
Performance on the box and block test with the paretic hand, quantified as the number of 2.5 cm^3 cubes grasped, lifted, and released to transfer between compartments correctly within 60 seconds.
Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test
The finger tracking test evaluates the subject's ability to track an oscillating wave with either their paretic or non-paretic finger. Subjects wore custom electro-goniometer braces on each hand, each of which included a potentiometer signaling extension and flexion of the index finger metacarpophalangeal joint. Subjects were presented with target stimuli with a random sinusoidal waveform and were instructed to move the corresponding index finger to match the target trace as the cursor moved across the screen with constant velocity. Performance was quantified by an accuracy index, calculated using the ratio of the error to the standard deviation of the target, normalized to the range of motion for each subject.
Changes in Inter-hemispheric Inhibition
Inter-hemispheric Inhibition was 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. IHI was measured by applying TMS to identified left and right motor hotspots at 1 mV threshold intensity, or 130% of the RMT if 1 mV threshold could not be identified, with single unilateral pulses and paired bilateral pulses. IHI was quantified by comparing the paired-pulse peak-to-peak motor evoked potential amplitudes to the corresponding single pulse MEP amplitudes for each direction of stimulation (ipsi- to contra-lesional and contra- to ipsi-lesional).
Full Information
NCT ID
NCT02132520
First Posted
April 8, 2014
Last Updated
October 30, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02132520
Brief Title
A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
Official Title
A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined Repetitive Transcranial Magnetic Stimulation and Brain-Computer Interface Training
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Stroke
Keywords
Hemiparesis, Stroke, Rehabilitation, Transcranial Magnetic Stimulation, Repetitive, Electroencephalography, Functional Neuroimaging, Brain-Computer Interface
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects receiving standard-of-care physical therapy only.
Arm Title
Sham rTMS + Real BCI Training
Arm Type
Sham Comparator
Arm Description
Subjects will receive sham rTMS followed by real BCI training.
Arm Title
Real rTMS + Real BCI Training
Arm Type
Active Comparator
Arm Description
Subjects will receive real rTMS followed by real BCI training.
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
Intervention Type
Behavioral
Intervention Name(s)
BCI Training
Intervention Description
BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
Primary Outcome Measure Information:
Title
Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI
Description
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.
Time Frame
Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Secondary Outcome Measure Information:
Title
Changes in Hand Motor Function as Measured by the Box and Block Test
Description
Performance on the box and block test with the paretic hand, quantified as the number of 2.5 cm^3 cubes grasped, lifted, and released to transfer between compartments correctly within 60 seconds.
Time Frame
Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Title
Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test
Description
The finger tracking test evaluates the subject's ability to track an oscillating wave with either their paretic or non-paretic finger. Subjects wore custom electro-goniometer braces on each hand, each of which included a potentiometer signaling extension and flexion of the index finger metacarpophalangeal joint. Subjects were presented with target stimuli with a random sinusoidal waveform and were instructed to move the corresponding index finger to match the target trace as the cursor moved across the screen with constant velocity. Performance was quantified by an accuracy index, calculated using the ratio of the error to the standard deviation of the target, normalized to the range of motion for each subject.
Time Frame
Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Title
Changes in Inter-hemispheric Inhibition
Description
Inter-hemispheric Inhibition was 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. IHI was measured by applying TMS to identified left and right motor hotspots at 1 mV threshold intensity, or 130% of the RMT if 1 mV threshold could not be identified, with single unilateral pulses and paired bilateral pulses. IHI was quantified by comparing the paired-pulse peak-to-peak motor evoked potential amplitudes to the corresponding single pulse MEP amplitudes for each direction of stimulation (ipsi- to contra-lesional and contra- to ipsi-lesional).
Time Frame
Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Other Pre-specified Outcome Measures:
Title
Subject Report of Symptoms
Description
The subject report of symptoms assesses whether subject experience any adverse effects as a result of participation in the study.
Time Frame
within 12 weeks of participation
Title
Changes in the Resting Motor Threshold
Description
The resting motor threshold is a measure of cortical excitability, and will be recorded for both the stroke and non-stroke hemispheres.
Time Frame
Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin He, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Science Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
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A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
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