HemiparesisNCT02132520
A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
A study testing rTMS and BCI Training in people with Hemiparesis and Stroke, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemiparesis, Stroke
- What is being tested?
- rTMS and BCI Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Science Institute
Minneapolis, Minnesota, 55455
About this study
Official title: A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined Repetitive Transcranial Magnetic Stimulation and Brain-Computer Interface Training
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.
Read the 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.
- Conditions
- Hemiparesis, Stroke
- Being tested
- rTMS, BCI Training
- Keywords
- Hemiparesis, Stroke, Rehabilitation, Transcranial Magnetic Stimulation, Repetitive, Electroencephalography, Functional Neuroimaging, Brain-Computer Interface
- Medical subject headings
- Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI TrainingBehavioural
BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: rTMS; Behavioral: BCI Training |
| Real rTMS + Real BCI Training | Active comparator | Subjects will receive real rTMS followed by real BCI training. Receives: Device: rTMS; Behavioral: BCI Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
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.
Measured: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
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).
Measured: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin He, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132520
- Sponsor's protocol ID
- 1306M36401
- Other IDs
- CBET-1264562
- Status last verified
- Oct 2019
- First submitted
- 8 Apr 2014
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined Repetitive Transcranial Magnetic Stimulation and Brain-Computer Interface Training
- ClinicalTrials.gov ID
- NCT02132520
- Acronym / sponsor ID
- 1306M36401
- Conditions
- Hemiparesis, Stroke
- Keywords
- Hemiparesis, Stroke, Rehabilitation, Transcranial Magnetic Stimulation, Repetitive, Electroencephalography, Functional Neuroimaging, Brain-Computer Interface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects receiving standard-of-care physical therapy only. |
| Sham rTMS + Real BCI Training | Sham comparator | Device: rTMS, Behavioral: BCI TrainingSubjects will receive sham rTMS followed by real BCI training. |
| Real rTMS + Real BCI Training | Active comparator | Device: rTMS, Behavioral: BCI TrainingSubjects will receive real rTMS followed by real BCI training. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- Personal history of epilepsy or seizures within the past 2 years
- Previous surgical procedure to the spinal cord
- Any MRI incompatible devices
- Pregnancy
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSLow frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes. | Device | Real rTMS + Real BCI Training, Sham rTMS + Real BCI Training |
| BCI TrainingBCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen. | Behavioural | Real rTMS + Real BCI Training, Sham rTMS + Real BCI Training |
Primary outcome
Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI
Time frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
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.
3 secondary outcomes
Changes in Hand Motor Function as Measured by the Box and Block Test
Time frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test
Time frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Changes in Inter-hemispheric Inhibition
Time frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin He, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS and BCI Training in people with Hemiparesis and Stroke, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI (time frame: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.