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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG053736 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Loss of mobility and cognitive ability are serious conditions that threaten the independence of older adults. The objective of this study is to initiate a line of research to develop a novel therapeutic intervention to enhance both mobility and cognition via neuroplasticity of frontal/executive circuits.
Frontal lobe dysfunction has been implicated as a factor contributing to gait deficits in some individuals with Alzheimer's disease, frontotemporal dementia and vascular dementia. There is a critical gap in knowledge about what therapeutic strategies are effective for maintaining or reinstating function in this critical brain region in order to preserve physical and cognitive health in older adults. The goal of our research is to develop a novel therapeutic intervention to enhance both mobility and cognition via neuroplasticity of frontal/executive control circuits. The Investigator will engage neuroplasticity of frontal circuits in two ways. The first is through neurorehabilitation with "complex walking tasks" (CWTs), such as obstacle crossing, obstacle avoidance and walking on non-uniform surfaces. CWTs are a potent behavioral approach for engaging prefrontal circuits. Furthermore, CWTs are crucial to successful ambulation in the home and community settings and therefore provide an ecologically valid therapeutic approach. The second approach that the Investigator will use to engage neuroplasticity of frontal circuits is anodal transcranial direct current stimulation (tDCS). Anodal tDCS is a safe, non-invasive neuromodulation technique. It has previously been shown to induce excitatory effects on brain tissue and, in single-session assessments, to improve performance during complex walking tasks. tDCS has also been shown to be an effective adjuvant for enhancing the effects of cognitive training. The objective of this study is to calculate effect size, establish variance of response and demonstrate feasibility of the experimental interventions in order to plan for a full scale clinical trial. Participants will include thirty older adults who demonstrate evidence of frontal/executive impairment. Participants will be randomized to one of three groups: 1) standard walking neurorehabilitation with sham tDCS ('standard/sham' group), 2) complex walking neurorehabilitation with sham tDCS ('complex/sham' group), or 3) complex walking neurorehabilitation with active anodal tDCS ('complex/active' group). Functional near infrared spectroscopy (fNIRS) will be used to explore intervention-induced changes in prefrontal cortical activity. Assessments will be conducted at baseline, post-treatment and 3-month follow up. The Investigator propose the following specific aims:
Specific Aim 1: Determine preliminary efficacy for recovery of mobility and cognitive function.
Specific Aim 2: Demonstrate feasibility/safety of tDCS as an adjuvant to rehabilitation.
Specific Aim 3: Explore the relationship between prefrontal activity and behavioral outcomes The data collected here will provide the information needed to justify and plan a future full scale clinical trial to assess the relative efficacy and underlying mechanisms of each intervention approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard walking with Sham tDCS | Active Comparator | Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS) |
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| Complex walking with Sham tDCS | Active Comparator | Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS) |
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| Complex walking with Active tDCS | Active Comparator | Neurorehabilitation of Complex Walking and Active Transcranial Direct Current Stimulation (Active tDCS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurorehabilitation of Standard Walking | Behavioral | Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking. |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility: Figure-of-eight Walking Test (Figure-8 Walk Test) | Time to complete a walking course at usual pace. The course is 15 feet in length and arranged as a Figure-8 pattern. | Change (value at 6 weeks minus value at baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Composite Executive Score on EXAMINER Battery | EXAMINER is an acronym for "Executive Abilities:Measures and Instruments for Neurobehavioral Evaluation and Research. EXAMINER is a battery of assessments that tests 7 domains of executive function separately and as a composite score. The composite score is based on Item Response Theory (logistic modeling) and ranges from a minimum value of -4 to a maximum value of 4. Higher scores indicate better performance. |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| David Clark, ScD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthStreet | Gainesville | Florida | 32608 | United States | ||
| UF Institute on Aging |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35410769 | Derived | Chatterjee SA, Seidler RD, Skinner JW, Lysne PE, Sumonthee C, Wu SS, Cohen RA, Rose DK, Woods AJ, Clark DJ. Effects of Prefrontal Transcranial Direct Current Stimulation on Retention of Performance Gains on an Obstacle Negotiation Task in Older Adults. Neuromodulation. 2023 Jun;26(4):829-839. doi: 10.1016/j.neurom.2022.02.231. Epub 2022 Apr 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Complex Walking With Active tDCS | Neurorehabilitation of Complex Walking and Active Transcranial Direct Current Stimulation (Active tDCS) Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs. Acive Transcranial Direct Current Stimulation (Active tDCS): tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Feb 19, 2019 |
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Participants will take part in a 6-week, 18-session neurorehabilitation led by qualified and trained study personnel. Participants will be randomized to one of three groups: 1) standard walking neurorehabilitation with sham tDCS ('standard/sham' group), 2) complex walking neurorehabilitation with sham tDCS ('complex/sham' group), or 3) complex walking neurorehabilitation with active anodal tDCS ('complex/active' group). Training logs will be maintained to gauge the content and intensity of training.
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To control for intensity, participants will maintain a rating of perceived exertion of 4 (moderate to strong) on the Borg Category/Ratio Scale during walking. Exertion will be adjusted by modifying walking speed and/or by modifying the rest time between walking bouts.
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| Neurorehabilitation of Complex Walking | Behavioral | Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs. |
|
| Sham Transcranial Direct Current Stimulation (Sham tDCS) | Device | tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits. |
|
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| Active Transcranial Direct Current Stimulation (Active tDCS) | Device | tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits. |
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| Change (value at 6 weeks minus value at baseline) |
| Gainesville |
| Florida |
| 32611 |
| United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| FG001 | Complex Walking With Sham tDCS | Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS) Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs. Sham Transcranial Direct Current Stimulation (Sham tDCS): Sham tDCS is a placebo to Active tDCS. |
| FG002 | Standard Walking With Sham tDCS | Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS) Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking. Sham Transcranial Direct Current Stimulation (Sham tDCS): Sham tDCS is a placebo to Active tDCS. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Complex Walking With Active tDCS | Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage B Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs. Active Transcranial Direct Current Stimulation (Active tDCS): tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits. |
| BG001 | Complex Walking With tDCS Dosage A | Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS) Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs. Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS |
| BG002 | Standard Walking With tDCS Dosage A | Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS) Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking. Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Typical Walking Speed | Mean | Standard Deviation | meters per second |
|
| 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 | Mobility: Figure-of-eight Walking Test (Figure-8 Walk Test) | Time to complete a walking course at usual pace. The course is 15 feet in length and arranged as a Figure-8 pattern. | Posted | Mean | Standard Deviation | seconds | Change (value at 6 weeks minus value at baseline) |
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| ||||||||||||||||||||||||||||||||
| Secondary | Cognitive Composite Executive Score on EXAMINER Battery | EXAMINER is an acronym for "Executive Abilities:Measures and Instruments for Neurobehavioral Evaluation and Research. EXAMINER is a battery of assessments that tests 7 domains of executive function separately and as a composite score. The composite score is based on Item Response Theory (logistic modeling) and ranges from a minimum value of -4 to a maximum value of 4. Higher scores indicate better performance. | Posted | Mean | Standard Deviation | units on a scale | Change (value at 6 weeks minus value at baseline) |
|
6 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 | Complex Walking With Active tDCS | Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage B Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs. Active Transcranial Direct Current Stimulation (Active tDCS): tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits. | 0 | 7 | 1 | 7 | 1 | 7 |
| EG001 | Complex Walking With Sham tDCS | Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS) Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs. Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Standard Walking With Sham tDCS | Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS) Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking. Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS | 0 | 7 | 0 | 7 | 2 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| kidney stones | Renal and urinary disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falling (no injury) | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Clark | University of Florida | 352-376-1611 | 105244 | davidclark@ufl.edu |
| Mar 28, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 3, 2019 | Mar 28, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 | Complex Walking With Sham tDCS | Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage A Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs. Transcranial Direct Current Stimulation (tDCS) dosage A: tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits. |
| OG002 | Standard Walking With Sham tDCS | Neurorehabilitation of Standard Walking and Transcranial Direct Current Stimulation (tDCS) dosage A Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking. Transcranial Direct Current Stimulation (tDCS) dosage A: tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits. |
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