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This study investigates the effects of sub-maximal exercise to task-failure (e.g., fatigue) with the less involved, or so-called non-paretic hand, in people who have experienced a stroke. In previous work the investigators found that non-paretic hand exercise to task-failure increased excitability of the motor cortex in the more involved hemisphere and produced behavioral improvements in the unexercised paretic hand. Importantly, the magnitude of increased brain excitability is greater than what has been observed following brain stimulation with either repetitive transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) and lasts longer. This approach could be implemented in the clinical setting and could be accessible to a greater number of people than brain stimulation. The investigators' goals in the current study are to: repeat previous findings in a different group of participants and investigate the neural mechanisms that produce brain and behavioral facilitation in order to inform development of this approach for clinical implementation.
The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand.
The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Task-failure, Extended Session | Experimental | Repeated sub-maximal gripping exercise with the less affected hand to task-failure - followed by repeated measurements (5) during recovery period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| submaximal exercise (grip) | Other | participants perform repeated gripping with visual feedback to task failure |
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| Measure | Description | Time Frame |
|---|---|---|
| Short Intracortical Inhibition (SICI) | SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation. In health, SICI is ~0.5. Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm. | baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total) |
| SICI Ratio | SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation. In health, SICI is ~0.5. Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm. | Baseline, pre-exercise of 8 repeated sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Box and Blocks Test (BBT) | The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute. Here function of the paretic hand was measured at each time point: baseline, post-task failure, 45min post, 90min post, 135min post, 180min post, 225min post-task failure to determine the change in paretic hand BBT performance following exercise to task-failure. Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve. Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolynn Patten, PhD | North Florida/South Georgia Veterans Health System, Gainesville, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | 32608 | United States |
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Participants identified by the VA Brain Rehabilitation Research Center (BRRC) screening and recruitment core enrolled between 2/1/2016 - 5/21/2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Task-Failure, Extended Session | individuals with upper-extremity impairment resulting from stroke, enrolled six or more months following stroke performed submaximal exercise (grip): participants performed submaximal gripping with the non-paretic hand to task failure, guided by visual feedback. Recovery was monitored for an extended period of 3:45 following task-failure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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No differences from inclusion criteria. As noted, data were not usable from 2 participants, thus only 13 data sets were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Task-failure, Extended Session | Exercise to fatigue followed by repeated monitoring of recovery until 3:45 after. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Short Intracortical Inhibition (SICI) | SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation. In health, SICI is ~0.5. Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm. | Only 13/15 data sets were usable for reasons explained elsewhere in the record. Thus, while 15 individuals were enrolled, we were able to analyze only 13 of these individuals' data. | Posted | Mean | Standard Error | SICI ratio | baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total) |
|
Study Duration, 2 years.
This was a low risk study of exercise.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Task-failure, Extended Session | individuals with upper-extremity impairment resulting from stroke, enrolled six or more months following stroke submaximal exercise (grip): participants performed repeated gripping with the non-paretic hand to task failure. Visual feedback was provided. |
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This was designed and intended as a small, pilot study to establish feasibility, refine methods, and generate preliminary data that could motivate sample size projections for future study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolynn Patten (Principal Investigator) | VA Northern California Health Care System | 916.724.5029 | carolynn.patten@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2019 | May 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018737 | Hand Strength |
| ID | Term |
|---|---|
| D053580 | Muscle Strength |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Prospective, repeated measures
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| baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total) |
| Box and Blocks Test (BBT) | The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute. Here function of the paretic hand was measured prior to exercise at each of 8 repeated sessions conducted twice weekly for 4 weeks to determine the change in paretic hand BBT performance following repeated sessions of exercise to task-failure. Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve. Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute. | baseline, pre-exercise of 8 repeated sessions |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Upper-extremity Fugl-Meyer Motor Assessment | The Fugl-Meyer Motor Assessment is a widely-used validated measure of motor impairment for individuals post-stroke. The upper-extremity component totals 66 points. Higher scores reflect less impairment/less severe hemiparesis, although 66 points is not equivalent to "normal" or scores achieved by non-disabled individuals. Lower scores reflect greater impairment/more severe hemiparesis. | Mean | Standard Deviation | units on a scale |
|
| Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) is a cognitive screening test designed to detect mild cognitive impairment and more serious cognitive disorders such as dementia. The scale ranges from 0 - 30 points; scores 26 and greater are considered normal. | Mean | Standard Deviation | units on a scale |
|
| Center for Epidemiologic Studies - Depression Scale | The Center for Epidemiologic Studies - Depression Scale (CES-D) was designed to measure self-reported symptoms of depression experienced in the prior week. Scores range from zero -to - 60 with higher scores representing greater incidence of symptomatology. | Mean | Standard Deviation | units on a scale |
|
| Fatigue Severity Scale | The Fatigue Severity Scale (FSS) is a patient-reported outcome evaluating the impact of fatigue on the individual designed to differentiate fatigue from clinical depression. Scores range from 0 - to - 7. People with depression alone score ~4.5, while people with fatigue related to an underlying neurological condition score ~6.5. | Mean | Standard Deviation | units on a scale |
|
| Task-Failure, Extended Session |
individuals with upper-extremity impairment following stroke submaximal exercise (grip): participants perform repeated gripping with visual feedback to task failure |
|
|
|
| Primary | SICI Ratio | SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation. In health, SICI is ~0.5. Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm. | Only 10/12 data sets analyzed because it was possible to induce SICI in only 10 individuals. | Posted | Mean | Standard Deviation | SICI ratio | Baseline, pre-exercise of 8 repeated sessions |
|
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|
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| Other Pre-specified | Box and Blocks Test (BBT) | The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute. Here function of the paretic hand was measured at each time point: baseline, post-task failure, 45min post, 90min post, 135min post, 180min post, 225min post-task failure to determine the change in paretic hand BBT performance following exercise to task-failure. Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve. Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute. | The Box and Blocks test (BBT) is an accepted measure of motor function/dexterity. Score reflect the number of 1" blocks moved from one half of a divided box to the other in 1 minute. Higher numbers indicate better performance. Only 13/15 data sets were analyzed because other data sets were not usable. | Posted | Mean | Standard Error | blocks | baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total) |
|
|
|
|
| Other Pre-specified | Box and Blocks Test (BBT) | The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute. Here function of the paretic hand was measured prior to exercise at each of 8 repeated sessions conducted twice weekly for 4 weeks to determine the change in paretic hand BBT performance following repeated sessions of exercise to task-failure. Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve. Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute. | BBT data were obtained in all 12 individuals at each of 8 sessions. | Posted | Mean | Standard Deviation | blocks | baseline, pre-exercise of 8 repeated sessions |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Title | Measurements |
|---|---|
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| Session4 |
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| Session5 |
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| Session6 |
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| Session7 |
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| Session8 |
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| Title | Measurements |
|---|---|
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| 90 min post-task-failure |
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| 135 min post-task-failure |
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| 180 min post-task-failure |
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| 225 min post-task-failure |
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| Title | Measurements |
|---|---|
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| Session4 |
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| Session5 |
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| Session6 |
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| Session7 |
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| Session8 |
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