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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX003115 | U.S. NIH Grant/Contract | View source |
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Older adults often experience substantial deficits in walking ability, especially for walking tasks that are more complex such as obstacle crossing. This is due in part to changes in the brain that make performance of physical and cognitive tasks more difficult. Rehabilitation can help to improve walking ability, but effective rehabilitation is time consuming and expensive. New approaches are needed to improve the efficiency of rehabilitation so that gains in walking ability are widely attainable. A promising strategy is to focus on enhancing motor learning, which is defined as improved ability to perform a motor task due to practice or experience. The investigators will investigate the use of non-invasive brain stimulation to increase motor learning and retention of the newly learned walking skills. The investigators will also use neuroimaging to assess brain characteristics that explain how motor learning works. The knowledge gained from this study is expected to contribute to better understanding of mechanistic targets and intervention approaches to improve rehabilitation of walking.
Aging often leads to substantial declines in walking function, especially for walking tasks that are more complex such as obstacle crossing. This is due in part to a lack of continued practice of complex walking (sedentary lifestyle) combined with age-related deficits of brain structure and the integrity of brain networks. Neurorehabilitation can contribute to recovery of lost walking function in older adults, but major and persistent improvements are elusive. A cornerstone of neurorehabilitation is motor learning, defined as an enduring change in the ability to perform a motor task due to practice or experience. Unfortunately, in most clinical settings, the time and cost demands of delivering a sufficiently intensive motor learning intervention is not feasible. There is a need for research to develop strategies for enhancing motor learning of walking ("locomotor learning") in order to improve the effectiveness of neurorehabilitation.
The objective of this study is to use non-invasive brain stimulation to augment locomotor learning and to investigate brain networks that are responsible for locomotor learning in mobility-compromised older adults. The investigators have shown that frontal brain regions, particularly prefrontal cortex, are crucial to control of complex walking tasks. The investigators' neuroimaging and neuromodulation studies also show that prefrontal cortex structure and network connectivity are important for acquisition and consolidation of new motor skills. However, a major gap exists regarding learning of walking tasks. The proposed study is designed to address this gap. The investigators' pilot data from older adults shows that prefrontal transcranial direct current stimulation (tDCS) administered during learning of a complex obstacle walking task contributes to multi-day retention of task performance. In the proposed study the investigators will build upon this pilot work by conducting a full scale trial that also investigates mechanisms related to brain structure, functional activity, and network connectivity. The investigators will address the following specific aims:
Specific Aim 1: Determine the extent to which prefrontal tDCS augments the effect of task practice for retention of performance on a complex obstacle walking task.
Specific Aim 2: Determine the extent to which retention of performance is associated with individual differences in baseline and practice-induced changes in brain measures (including gray matter volume and brain network segregation).
Specific Aim 3: Investigate the extent to which tDCS modifies resting state network segregation.
The investigators anticipate that prefrontal tDCS will augment retention of locomotor learning, and that the data will provide the first evidence of specific brain mechanisms responsible for locomotor learning/retention in older adults with mobility deficits. This new knowledge will provide a clinically feasible intervention approach as well as reveal mechanistic targets for future interventions to enhance locomotor learning and retention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | 20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task |
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| Sham tDCS | Sham Comparator | 30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| practice of a complex walking task | Behavioral | walking over obstacles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking Speed Change From Baseline | Change in the fastest safe walking speed over a complex walking course | Measured at follow up visit (approximately three weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Prefrontal Cortex Gray Matter Volume Change From Baseline | Change in the volume of gray matter in the prefrontal cortex, as measured by MRI | Measured at follow up visit (approximately three weeks after baseline) |
| Brain Resting State Network Segregation (Z-transformed Correlation Coefficient) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Clark, DSc | 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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Participants were screened to ensure they met all inclusion/exclusion criteria, did not have major disease or injury affecting brain function or walking function, were medically stable, and could safely participate in the study protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | 20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task |
| FG001 | Sham tDCS | 30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
These numbers are those who passed the onsite screening visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | 20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task |
| BG001 | Sham tDCS | 30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | These numbers are those who passed the onsite screening visit. |
| 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 | Walking Speed Change From Baseline | Change in the fastest safe walking speed over a complex walking course | Posted | Mean | Standard Deviation | meters per second | Measured at follow up visit (approximately three weeks after baseline) |
|
From enrollment until the end of follow-up, up to 8 weeks
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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 | Active tDCS | 20 minutes of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal injury (not serious) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Clark | Malcom Randall VA Medical Center | 3523761611 | 105244 | david.clark1@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 23, 2023 | Jul 25, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 23, 2023 | Aug 28, 2024 | ICF_000.pdf |
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Participants will randomized to one of two dosages of transcranial direct current stimulation (tDCS): Dosage A or Dosage B
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Participants will not be told which dosage group they are assigned to. Outcomes Assessors will not be told which dosage group the participant was randomized to.
| Active transcranial direct current stimulation (Active tDCS) | Device | mild electrical stimulation delivered to the frontal region of the brain |
|
| Sham transcranial direct current stimulation (Sham tDCS) | Device | 30 seconds of mild electrical stimulation delivered to the frontal region of the brain |
|
Resting-state functional MRI was used to measure the segregation of large-scale brain networks. Connectivity strength was quantified using Fisher z-transformed correlation coefficients, averaged across regions of interest within each network. Results are reported as mean z-scores for each group. Higher values reflect greater segregation (i.e., stronger within-network compared to between-network connectivity). |
| Measured at follow up visit (approximately three weeks after baseline) |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | These numbers are those who passed the onsite screening visit. | Count of Participants | Participants |
|
| Race (NIH/OMB) | These numbers are those who passed the onsite screening visit. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | These numbers are those who passed the onsite screening visit. | Count of Participants | Participants |
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| Walking speed | preferred walking speed over 10 meters | These numbers are those who passed the onsite screening visit. | Mean | Standard Deviation | meters per second |
|
| Montreal Cognitive Assessment | The scores range between 0 to 30 points; higher values represent a better outcome. | These numbers are those who passed the onsite screening visit. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Prefrontal Cortex Gray Matter Volume Change From Baseline | Change in the volume of gray matter in the prefrontal cortex, as measured by MRI | Some participants did not complete the MRI assessment at baseline or at follow-up due to technical or logistical difficulties. | Posted | Mean | Standard Deviation | cubic millimeters | Measured at follow up visit (approximately three weeks after baseline) |
|
|
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| Secondary | Brain Resting State Network Segregation (Z-transformed Correlation Coefficient) | Resting-state functional MRI was used to measure the segregation of large-scale brain networks. Connectivity strength was quantified using Fisher z-transformed correlation coefficients, averaged across regions of interest within each network. Results are reported as mean z-scores for each group. Higher values reflect greater segregation (i.e., stronger within-network compared to between-network connectivity). | A total of 65 participants underwent MRI imaging, of which only 50 participants were included. Eight participants were missing either baseline or post-assessment scan. Four participants did not complete all necessary scanning sequences. | Posted | Mean | Standard Deviation | z-transformed correlation coefficient | Measured at follow up visit (approximately three weeks after baseline) |
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| 0 |
| 32 |
| 0 |
| 32 |
| 1 |
| 32 |
| EG001 | Sham tDCS | 30 seconds of mild electrical stimulation delivered to the frontal region of the brain during practice of a complex walking task | 0 | 36 | 0 | 36 | 1 | 36 |
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