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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK1RX003954-01A1 | U.S. NIH Grant/Contract | View source |
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Older adults and stroke survivors often have difficulty performing complex walking tasks, due in part to changes in the brain. One task often overlooked is turning, which can lead to injury when performed poorly. The investigators will use non-invasive brain stimulation to assess brain activity and relate those observations to turning performance in older adults and stroke survivors.
This study is associated with an ongoing Clinical Trial (NCT03790657) called the CONTROL Walking Study, which combines locomotor learning and a form of non-invasive electrical brain stimulation call transcranial direct current stimulation (tDCS). The CONTROL Walking Study, randomly places participants into one of two experimental groups (transcranial direct current stimulation or sham stimulation). Following group placement participants complete a 2 week long walking and turning locomotor learning intervention while receiving a group dependent the form of tDCS or sham stimulation.
In leveraging the CONTROL Walking Study infrastructure to further examine the neural control of turning while walking, which is often impaired for older adults and people who have had a stroke. This study will assess neurophysiological brain function using transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation as well as assessing multiple forms of turning performance in older adults. Transcranial magnetic stimulation (TMS) will be used to assess cortical inhibitory neurophysiological function in motor networks of the brain. Importantly, recent work demonstrates significant associations between brain excitatory/inhibitory function and turning performance in older adults, although these results remain largely preliminary.
Therefore, the objective of this proposal is to further elucidate associations between neurophysiological function (measured with TMS) and 360 degree and 180 degree turning performance. The investigators will address the following specific aims:
Specific Aim 1 will test the hypothesis that greater cortical inhibition will be associated with shorter turn duration for 360 degree turns and 180 degree turns.
Specific Aim 2 will test the hypothesis that participants with greater baseline cortical inhibition will demonstrate larger 360 degree and 180 degree turning performance gains (i.e., shorter turn durations).
This new knowledge will provide additional information as to the neural mechanisms associated with turning performance in older adults. Moreover, these results could reveal mechanistic targets for future interventions to enhance turning performance learning and retention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Stimulation | Sham Comparator | Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. |
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| Transcranial Direct Current Simulation | Experimental | Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Locomotor Learning | Behavioral | Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Cortical Silent Period (CSP) (ms) | Cortical Silent Period (CSP) is a single-pulse TMS measure of GABA-mediated cortical inhibition, in which stimulation is applied to the motor cortex while participants are activating a target muscle (here, the tibialis anterior muscle), resulting in a brief reduction in muscle activity. CSP is measured as the time during which the muscle activity is less than the pre-simulation muscle activity level until the return of voluntary muscle activity. CSP is measured in milliseconds (ms). | 30 minutes, Measured at Baseline |
| 360 Degree Turn Duration From Baseline | Change in 360 degree turn duration during a 360 degree turn test | Measured at follow up visit (approximately three weeks after baseline) |
| 180 Degree Turn Duration From Baseline | Change in 180 degree turn duration as measured during a 2 minute walking task where participants walk back and forth down a corridor. | Measured at follow up visit (approximately three weeks after baseline) |
| Resting Motor Threshold (Percent of Machine Output) | Resting motor threshold (rMT) is obtained by single-pulse TMS and assesses voltage-gated sodium-channel-mediated cortical excitability. rMT is the minimum intensity (% machine output) of stimulation needed to repeatedly evoke a motor evoked potential (MEP) of at least 50 microvolts in over 50% of trials. It is reported as a percentage of total machine output. | 20 minutes, Measured at Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Katz Independence Questionnaire | 6-item participant reported questionnaire assessing level of independence [bathing, dressing, toileting, transferring, continence, feeding]. Total scores range: 0-6, the higher the score, the more independent. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clayton W Swanson, 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 | 32608-1135 | United States |
A limited dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
The Limited Dataset will be completed after the study is completed and primary/secondary data accepted for publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Stimulation | Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. Experimental: Locomotor Learning: Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation. |
| FG001 | Transcranial Direct Current Simulation | Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. Experimental: Locomotor Learning: Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Stimulation | Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. Experimental: Locomotor Learning: Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation. |
| 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, Categorical | Count of Participants |
| 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 | Duration of Cortical Silent Period (CSP) (ms) | Cortical Silent Period (CSP) is a single-pulse TMS measure of GABA-mediated cortical inhibition, in which stimulation is applied to the motor cortex while participants are activating a target muscle (here, the tibialis anterior muscle), resulting in a brief reduction in muscle activity. CSP is measured as the time during which the muscle activity is less than the pre-simulation muscle activity level until the return of voluntary muscle activity. CSP is measured in milliseconds (ms). | Cortical silent period (CSP) data could not be collected from eight participants in the sham group and four participants in the active tDCS group. In these cases, a reliable cortical stimulation site (i.e., motor hotspot) and consistent motor evoked potential (MEP) responses could not be identified, which are required to determine the resting motor threshold necessary for CSP assessment. | Posted | Mean | Standard Deviation | milliseconds (ms) | 30 minutes, Measured at Baseline |
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Adverse events were monitored from the baseline visit through the follow-up visit, approximately 3 weeks later (i.e., a monitoring period of about 3 weeks per participant).
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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 | Sham Stimulation | Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. Experimental: Locomotor Learning: Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation. |
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Technical challenges during TMS data collection led to incomplete or unreliable neurophysiological data for several participants, limiting the interpretability of outcomes. Additionally, the overall sample size was small, which constrains the generalizability of the findings. The TMS component of the protocol required an FDA risk determination, which delayed the initiation of data collection and further contributed to the limited number of participants available for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Clayton Swanson | Veterans Health Administration | 3523761611 | 107583 | clayton.swanson@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 | Oct 13, 2022 | Aug 26, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2023 | Jun 6, 2025 | ICF_002.pdf |
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Participants will randomized to either receive transcranial direct current stimulation (tDCS) or sham
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Participants will not be told which group (tDCS or sham) they are assigned to. Outcomes Assessors will not be told which group the participant was randomized to.
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| BG001 | Transcranial Direct Current Simulation | Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. Experimental: Locomotor Learning: Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | 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 | Count of Participants | Participants |
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| Height | Mean | Full Range | Meters (m) |
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| Weight | Mean | Full Range | Kilograms (kg) |
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| BMI | Mean | Full Range | weight (kg) / [height (m)]2 |
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| Sham Stimulation |
Participants will undergo 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. Experimental: Locomotor Learning: Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation. |
| OG001 | Transcranial Direct Current Simulation | Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. Experimental: Locomotor Learning: Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation. |
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| Primary | 360 Degree Turn Duration From Baseline | Change in 360 degree turn duration during a 360 degree turn test | There was a data collection error for one participant in the sham group. There was one data collection error and one participant withdrawal in the tDCS group. | Posted | Mean | Full Range | Seconds (s) | Measured at follow up visit (approximately three weeks after baseline) |
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| Primary | 180 Degree Turn Duration From Baseline | Change in 180 degree turn duration as measured during a 2 minute walking task where participants walk back and forth down a corridor. | One participant from both groups had data collection errors, one additional participant from the active tDCS group withdrew from the study. | Posted | Mean | Full Range | Seconds (s) | Measured at follow up visit (approximately three weeks after baseline) |
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| Primary | Resting Motor Threshold (Percent of Machine Output) | Resting motor threshold (rMT) is obtained by single-pulse TMS and assesses voltage-gated sodium-channel-mediated cortical excitability. rMT is the minimum intensity (% machine output) of stimulation needed to repeatedly evoke a motor evoked potential (MEP) of at least 50 microvolts in over 50% of trials. It is reported as a percentage of total machine output. | Reliable cortical stimulation site (i.e., motor hotspot) and consistent motor evoked potential (MEP) responses could not be identified, which are required to determine the resting motor threshold. | Posted | Mean | Full Range | % Maximal Stimulator Output (%MSO) | 20 minutes, Measured at Baseline |
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| Secondary | Katz Independence Questionnaire | 6-item participant reported questionnaire assessing level of independence [bathing, dressing, toileting, transferring, continence, feeding]. Total scores range: 0-6, the higher the score, the more independent. | Posted | Median | Full Range | score on a scale | Baseline |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Transcranial Direct Current Simulation | Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. Experimental: Locomotor Learning: Participants will undergo four sessions of locomotor and turn learning. Locomotor learning will involve practicing walking over different terrains (i.e., soft and firm mats) and obstacles at different walking speeds (slow or fast) and turning practice at each end of the walking course. The full cohort will undergo either transcranial direct current stimulation or sham stimulation. | 0 | 5 | 0 | 5 | 0 | 5 |
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