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| ID | Type | Description | Link |
|---|---|---|---|
| K01AG075252 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Walking is a complex and continuous task that entails repetitive motions of the body. Relatively high gait variability sensitively predicts falls and cognitive decline in older adults. Previous work has identified an unique brain network relationship linked to gait variability and its relevant cognitive function (i.e., sustained attention). This project aims to develop a non-invasive brain stimulation montage designed to modulate the shared brain networks dynamics and to demonstrate its effects on resting state functional connectivity, gait and cognitive performance in older adults at risk for falls.
This is a randomized controlled trial to examine the efficacy of a non-invasive brain stimulation intervention of tDCS to improve unsteady gait in older adults. The investigators will enroll 30 older adults with elevated gait variability. Participants will be randomized into one of two arms: a) 10 sessions of tDCS and b) 5 sessions of sham stimulation followed by 5 sessions of tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention - consisting of 10, once-daily, 20-min stimulation sessions over a 2-week period, and a set of post-intervention assessments. This project is expected to demonstrate that tDCS can be used to reduce gait variability in older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS intervention | Experimental | Ten, once-daily, 20-min sessions of tDCS will be provided over two consecutive weeks. |
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| Sham and then tDCS | Sham Comparator | Five, once-daily, 20-min sessions of sham in week one followed by five, once-daily, 20-min sessions of tDCS in week two. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) (active) | Device | The tDCS montage is developed to modulate the functional connectivity between the dorsal attention network and the default network. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait variability | This measure is captured by both Mobility Lab (APDM Inc) and the smart phone App. Gait variability is defined as the coefficient of variation to validated stride times. | Baseline, Immediate post-intervention, 1 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed | This measure is captured by Mobility Lab (APDM InC). Gait speed id defined by the time one takes to walk a specified distance. | Baseline, Immediate post-intervention, 1 month follow up |
| Dual-task gait performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| On-Yee Lo, Ph.D. | Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife | Boston | Massachusetts | 02131 | United States |
The prospective plan is to have data available in a data repository.
The data will be available when the data are unblinded.
Depending on the repositories in which the data is held. Use of the data will be restricted by permission and appropriate human subjects review of the prospective project.
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| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Transcranial direct current stimulation (tDCS) (Sham) | Device | The tDCS "Acti-" Sham montage is developed to recreate the cutaneous sensations associated with tDCS, yet essentially a null electrical field over the networks of interest. |
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Participants will be asked to walk under two conditions: 1) walk at a comfortable, self-selected speed and 2) walk while counting backward by 1' or 3's from a random 3-digit number. Dual-task gait characteristics will be captured while the participants concurrently walk and count. We will further calculate the cost one takes to complete the dual-task walking from walking at a comfortable, self-selected speed.
| Baseline, Immediate post-intervention, 1 month follow up |
| Accuracy (d prime) on the gradual onset continuous performance task (gradCPT) | The gradCPT is a computer-based cognitive task designed to measure sustained attention. Accuracy (d prime) on the gradCPT can be derived from the gradCPT analysis tool box. | Baseline, Immediate post-intervention, 1 month follow up |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |