Stroke, Stroke, Chronic, Stroke, Middle Cerebral Artery With Infarction
Conditions
Keywords
Transcranial Magnetic Stimulation, Motor Impairment, Rehabilitation, Motor Learning
Brief summary
This study uses a form on non-invasive brain stimulation called transcranial magnetic stimulation to understand 1) understand how the brain learns post-stroke and 2) assess non-invasive brain stimulation as an addition to current stroke rehabilitation approaches. In two study arms the investigators will compare the effect of active transcranial magnetic stimulation paired with motor practice with placebo (or sham) transcranial magnetic stimulation paired with the same motor practice.
Detailed description
Stroke is the leading cause of permanent disability in the United States. In the absence of treatments to restore the lost tissue, clinical scientists have focused upon repetitive forced used of the paretic limb to promote neural reorganization in preserved tissue and reduce disability. However, forced use interventions are time intensive and the extent of functional recovery is variable. One potential contributor to this variability is the potential trade-off between compensatory cognitive motor control strategies and the extent of procedural learning that can occur. Compensatory strategies adopted by patients may produce quick short-term increases in performance but retard slower sustained improvements by interfering with development of procedural learning. Consistent with this hypothesis, the investigators' previous work documents an increased reliance upon dorsolateral prefrontal cortex during performance of learned skills post-stoke. However, the investigators' previous work also demonstrates that the effect of increased activity in dorsolateral prefrontal cortex may limit reorganization in important areas involved in the consolidation of practice thereby limiting functional recovery post-stroke. Transcranial magnetic stimulation offers a unique opportunity to investigate the relationship between dorsolateral prefrontal cortex activity and consolidation of motor practice/rehabilitaion post-stroke. Here the investigators' objective is to determine whether suppression of the contralesional dorsolateral prefrontal cortex, with continuous theta burst transcranial magnetic brain stimulation (cTBS), a form of transcranial magnetic stimulation, prior to motor practice enhances brain reorganization in critical areas and leads to greater sustained improvements in motor ability over time. The proposed work will enhance the understanding of motor learning post-stroke and provide preliminary evidence for the benefits of dorsolateral prefrontal cTBS as an adjunct to current rehabilitation interventions.
Interventions
DEVICEActive continuous theta burst stimulation (cTBS)
Active cTBS over dorsolateral prefrontal cortex that has an effect upon dorsolateral prefrontal cortex brain activity.
DEVICEPlacebo (Sham) continuous theta burst stimulation
Sham stimulation over dorsolateral prefrontal cortex that looks and sounds like active cTBS but does not have any effect upon dorsolateral prefrontal cortex brain activity.
BEHAVIORALMotor Practice
Upper limb reaching task to be practiced. Practice will be paired with Active/Sham stimulation. Twenty trials will occur before Active/Sham stimulation. 40 trials will be practiced after Active/Sham stimulation.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 50-75 years 2. movement-related deficit associated with first time middle cerebral artery stroke 3. greater than 6-months post-stroke 4. Fugl-Meyer score between 15 and 60 5. ability to elicit a motor evoked potential from the ipsilesional cortex
Exclusion criteria
1. a score \<27 on the Mini-Mental Status Exam 2. a score of \<123 on the Mattis Dementia Rating Scale 3. a score of \<13 on the Frenchay Aphasia Screen 4. a history of seizure/epilepsy, head trauma, major psychiatric diagnosis, neurodegenerative disorder or substance abuse 5. a history of congestive heart failure 6. systolic blood pressure above 120 mmHg and/or diastolic pressure above 80 mmHg 7. the taking of any GABAergic, NMDA-receptor antagonist or other drug known to influence the neural receptors that facilitate neural plasticity 8. an infarct resulting from ischemic stroke of anterior or posterior cerebral artery OR an infarct that encroaches within 2cm of the site of cTBS stimulation 9. absence of an MEP in response to single pulse transcranial magnetic stimulation over ipsilesional M1 and 10) any other contraindication to TMS or MRI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Sequential Response Time to Post-Intervention | Baseline and post-intervention | Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to any practice and at a delayed retention test (e.g. no warm up or preceding practice) post-intervention. Change between the baseline average and post-intervention average was also calculated by subtracting post-intervention score from pre-intervention score. Positive numbers represent improvement in ability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Baseline and post-intervention | The Jebsen-Taylor Hand Function Test is comprised of a series of unimanual tasks required for activities of daily living. Time to complete the Jebsen-Taylor Hand Function Test was assessed at baseline and post-intervention by taking the aggregate time to complete each activity. Change in time to complete the Jebsen-Taylor Hand Function Test between the baseline and post-intervention tests was derived by subtracting post-intervention score from baseline score. Positive scores indicate improvement in functional motor ability. |
| Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) | Within session baseline to ~8 minutes post-application of non-invasive stimulation within the same session | Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to application of Active+Motor Practice or Sham+Motor Practice for each intervention session and the first ten sequences of practice immediately following the specific form of non-invasive brain stimulation within each session. Change within a session was calculated by subtracting the post-stimulation score from the pre-stimulation score within a session. Positive values represent improved ability. |
| Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention | Baseline and post-intervention | Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts. |
| Change From Baseline in Cortical Excitability Post-Intervention | Baseline and post-intervention | Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts. Change in motor evoked potential amplitude elicited by transcranial magnetic stimulation intensities of 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold. Values are expressed percent change relative to pre-baseline values. Positive numbers represent an increase motor evoked potential from pre-baseline to post-intervention. |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted through mailings to individuals identified as having been admitted to the University of Michigan Health System in the past 5 years (from 01/01/2012 to 01/27/2017) for treatment of middle cerebral artery stroke. Mailings were sent to those individuals with zip codes in the state of Michigan and northwest Ohio.
Pre-assignment details
Enrolled participants were excluded prior to randomization for: known contraindication to the transcranial magnetic stimulation intervention (n=1) and a broken foot, not study related, between enrollment and randomization (n=1).
Participants by arm
| Arm | Count |
|---|---|
| Active+Motor Practice, Then Sham+Motor Practice Participants first completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation over dorsolateral prefrontal cortex. | 5 |
| Sham+Motor Practice, Then Active+Motor Practice Participants first completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation over dorsolateral prefrontal cortex. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Failure to meet inclusion criterion | 1 | 0 |
| First Intervention | Lost to Follow-up | 0 | 1 |
| Washout | Lost to Follow-up | 1 | 2 |
| Washout | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Active+Motor Practice, Then Sham+Motor Practice | Sham+Motor Practice, Then Active+Motor Practice | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 10 | 59 years STANDARD_DEVIATION 10 | 58 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fugl-Meyer Assessment of Motor Recovery After Stroke (Upper Limb) | 50 units on a scale STANDARD_DEVIATION 17 | 48 units on a scale STANDARD_DEVIATION 24 | 49 units on a scale STANDARD_DEVIATION 20 |
| Mini-Mental State Examination | 30 units on a scale STANDARD_DEVIATION 1 | 27 units on a scale STANDARD_DEVIATION 3 | 29 units on a scale STANDARD_DEVIATION 2 |
| Montreal Cognitive Assessment | 28 units on a scale STANDARD_DEVIATION 2 | 24 units on a scale STANDARD_DEVIATION 3 | 26 units on a scale STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
| Stroke Affected Hemisphere Left Hemisphere | 2 Participants | 4 Participants | 6 Participants |
| Stroke Affected Hemisphere Right Hemisphere | 3 Participants | 1 Participants | 4 Participants |
| Trail Making Test A | 29.6 seconds STANDARD_DEVIATION 6.9 | 31.1 seconds STANDARD_DEVIATION 13.3 | 30.3 seconds STANDARD_DEVIATION 9.5 |
| Trail Making Test B | 29.6 seconds STANDARD_DEVIATION 33.1 | 89.7 seconds STANDARD_DEVIATION 26.2 | 75.3 seconds STANDARD_DEVIATION 31.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Change From Baseline in Sequential Response Time to Post-Intervention
Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to any practice and at a delayed retention test (e.g. no warm up or preceding practice) post-intervention. Change between the baseline average and post-intervention average was also calculated by subtracting post-intervention score from pre-intervention score. Positive numbers represent improvement in ability.
Time frame: Baseline and post-intervention
Population: All participants who completed at least one arm of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active+Motor Practice | Change From Baseline in Sequential Response Time to Post-Intervention | Time to Complete Sequence (Baseline) | 8.68 seconds | Standard Deviation 2.06 |
| Active+Motor Practice | Change From Baseline in Sequential Response Time to Post-Intervention | Time to Complete Sequence (Delayed Retention) | 8.32 seconds | Standard Deviation 1.55 |
| Active+Motor Practice | Change From Baseline in Sequential Response Time to Post-Intervention | Change in Time (Pre to Post) | 0.37 seconds | Standard Deviation 0.65 |
| Sham+Motor Practice | Change From Baseline in Sequential Response Time to Post-Intervention | Time to Complete Sequence (Baseline) | 8.84 seconds | Standard Deviation 1.47 |
| Sham+Motor Practice | Change From Baseline in Sequential Response Time to Post-Intervention | Time to Complete Sequence (Delayed Retention) | 7.96 seconds | Standard Deviation 1.04 |
| Sham+Motor Practice | Change From Baseline in Sequential Response Time to Post-Intervention | Change in Time (Pre to Post) | 0.88 seconds | Standard Deviation 0.63 |
Comparison: Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Active arm. Cohen's d was calculated as a measure of effect size.
Comparison: Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Sham arm. Cohen's d was calculated as a measure of effect size.
Secondary
Change From Baseline in Cortical Excitability Post-Intervention
Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts. Change in motor evoked potential amplitude elicited by transcranial magnetic stimulation intensities of 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold. Values are expressed percent change relative to pre-baseline values. Positive numbers represent an increase motor evoked potential from pre-baseline to post-intervention.
Time frame: Baseline and post-intervention
Population: All participants who completed at least one arm of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active+Motor Practice | Change From Baseline in Cortical Excitability Post-Intervention | % change in MEP (120% RMT) | -26 percentage change | Standard Deviation 35 |
| Active+Motor Practice | Change From Baseline in Cortical Excitability Post-Intervention | % change in MEP (150% RMT) | -17 percentage change | Standard Deviation 37 |
| Sham+Motor Practice | Change From Baseline in Cortical Excitability Post-Intervention | % change in MEP (120% RMT) | -19 percentage change | Standard Deviation 58 |
| Sham+Motor Practice | Change From Baseline in Cortical Excitability Post-Intervention | % change in MEP (150% RMT) | 25 percentage change | Standard Deviation 17 |
Comparison: Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Comparison quantified as effect size using Cohen's d.
Comparison: Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Comparison quantified as effect size using Cohen's d.
Secondary
Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test
The Jebsen-Taylor Hand Function Test is comprised of a series of unimanual tasks required for activities of daily living. Time to complete the Jebsen-Taylor Hand Function Test was assessed at baseline and post-intervention by taking the aggregate time to complete each activity. Change in time to complete the Jebsen-Taylor Hand Function Test between the baseline and post-intervention tests was derived by subtracting post-intervention score from baseline score. Positive scores indicate improvement in functional motor ability.
Time frame: Baseline and post-intervention
Population: All participants who completed at least one arm of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Pre Time to Complete (Stroke Affected Limb) | 95.68 seconds | Standard Deviation 51.71 |
| Active+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Post Time to Complete (Stroke Affected Limb) | 100.05 seconds | Standard Deviation 60.47 |
| Active+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Change Pre to Post (Stroke Affected Limb) | -4.38 seconds | Standard Deviation 8.95 |
| Active+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Pre Time to Complete (Non-Stroke Affected Limb) | 55.75 seconds | Standard Deviation 11.22 |
| Active+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Post Time to Complete (Non-Stroke Affected Limb) | 51.97 seconds | Standard Deviation 8.25 |
| Active+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Change Pre to Post (Non-Stroke Affected Limb) | 3.78 seconds | Standard Deviation 5.33 |
| Sham+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Post Time to Complete (Non-Stroke Affected Limb) | 64.95 seconds | Standard Deviation 24.07 |
| Sham+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Pre Time to Complete (Stroke Affected Limb) | 86.07 seconds | Standard Deviation 17.78 |
| Sham+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Pre Time to Complete (Non-Stroke Affected Limb) | 66.67 seconds | Standard Deviation 20.87 |
| Sham+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Post Time to Complete (Stroke Affected Limb) | 76.27 seconds | Standard Deviation 20.97 |
| Sham+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Change Pre to Post (Non-Stroke Affected Limb) | 1.72 seconds | Standard Deviation 5.4 |
| Sham+Motor Practice | Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test | Change Pre to Post (Stroke Affected Limb) | 9.80 seconds | Standard Deviation 6.14 |
Comparison: The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.
Comparison: The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.
Comparison: Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the stroke affected limb. Cohen's d was calculated as a measure of effect size.
Comparison: The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.
Comparison: The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.
Comparison: Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the non-stroke affected limb. Cohen's d was calculated as a measure of effect size.
Secondary
Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session)
Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to application of Active+Motor Practice or Sham+Motor Practice for each intervention session and the first ten sequences of practice immediately following the specific form of non-invasive brain stimulation within each session. Change within a session was calculated by subtracting the post-stimulation score from the pre-stimulation score within a session. Positive values represent improved ability.
Time frame: Within session baseline to ~8 minutes post-application of non-invasive stimulation within the same session
Population: All participants who completed at least one arm of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active+Motor Practice | Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) | Session 1 | 0.41 seconds | Standard Deviation 0.7 |
| Active+Motor Practice | Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) | Session 2 | 0.72 seconds | Standard Deviation 1.97 |
| Active+Motor Practice | Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) | Session 3 | -0.20 seconds | Standard Deviation 0.6 |
| Active+Motor Practice | Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) | Session 4 | 0.35 seconds | Standard Deviation 0.46 |
| Sham+Motor Practice | Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) | Session 4 | 0.23 seconds | Standard Deviation 0.39 |
| Sham+Motor Practice | Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) | Session 1 | 0.89 seconds | Standard Deviation 0.36 |
| Sham+Motor Practice | Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) | Session 3 | 0.22 seconds | Standard Deviation 0.62 |
| Sham+Motor Practice | Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) | Session 2 | 0.80 seconds | Standard Deviation 1.86 |
Comparison: The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 1 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.
Comparison: The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 2 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.
Comparison: The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 3 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.
Comparison: The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 4 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.
Secondary
Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention
Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts.
Time frame: Baseline and post-intervention
Population: All participants who completed at least one arm of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active+Motor Practice | Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention | MEP Amplitude Pre (120% of RMT) | 1558 microvolts | Standard Deviation 1020 |
| Active+Motor Practice | Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention | MEP Amplitude Pre (150% of RMT) | 2750 microvolts | Standard Deviation 2172 |
| Active+Motor Practice | Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention | MEP Amplitude Post (150% of RMT) | 2008 microvolts | Standard Deviation 2062 |
| Active+Motor Practice | Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention | MEP Amplitude Post (120% of RMT) | 1216 microvolts | Standard Deviation 1161 |
| Sham+Motor Practice | Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention | MEP Amplitude Post (150% of RMT) | 2495 microvolts | Standard Deviation 609 |
| Sham+Motor Practice | Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention | MEP Amplitude Pre (120% of RMT) | 971 microvolts | Standard Deviation 709 |
| Sham+Motor Practice | Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention | MEP Amplitude Post (120% of RMT) | 511 microvolts | Standard Deviation 279 |
| Sham+Motor Practice | Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention | MEP Amplitude Pre (150% of RMT) | 1977 microvolts | Standard Deviation 218 |
Comparison: Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.
Comparison: Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.
Comparison: Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.
Comparison: Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.