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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG076708 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| BrightFocus Foundation | OTHER |
| National Institute on Aging (NIA) | NIH |
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This project aims to examine the efficacy of remote, caregiver-led tES/brain stimulation intervention targeted to improve memory, mobility, and executive functioning among older adults with mild cognitive impairment or mild dementia.
This is a randomized controlled trial to test the efficacy of a home-based brain stimulation intervention of tACS (for angular gyrus) and tDCS (for the prefrontal cortex) to improve memory, mobility, and executive function. It will include 144 older adults with mild dementia or mild cognitive impairment and their caregiver/administrator who will be trained to lead the remote, home-based brain stimulation. Participants will be randomized into one of four conditions, a) active combination of tACS + tDCS, b) combination of active tACS + sham tDCS, c) combination of sham tACS + active tDCS, and d) combination of sham tACS + sham tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention--consisting of 20, once-daily 30-min stimulation sessions administered over a 4-week period, and a set of post-intervention assessments (immediately following brain stimulation, 3 months post-brain stimulation, and 6 months post-brain stimulation). This project is expected to demonstrate that tACS and tDCS can be combined to optimize the functional impact of a home-based tES intervention for older adults with mild dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tACS(AG) + tDCS(PFC) combo active | Experimental | Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As). |
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| tACS(AG) active + tDCS(PFC) sham | Active Comparator | Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As). |
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| tACS(AG) sham + tDCS(PFC) active | Active Comparator | Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As). |
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| tACS(AG) sham + tDCS(PFC) sham | Sham Comparator | Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active) | Device | Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall | This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time. Total recall is measured by the total number of words out of 15 the participant is able to recall. Scores range from 0 to 15. | baseline, immediate post-intervention, 3 month follow up , 6 month follow up |
| Change in Dual Task Cost to Gait | This measure is captured by Mobility Labâ„¢ (APDM Inc) software while the participant is walking with sensors at a) normal speed (speed for single task) and b) walking while counting backwards by 3's or 1's (speed dual task). The formula for cost of the dual task to gait is: (speedsingletask-speeddualtask)/speedsingletask)*100). Range for dual task cost is as follows: High Risk for falls > 0.2, Moderate Risk for falls <= 0.2, Low Risk < 0.1. | baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Activity Questionnaire | This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:
The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up. |
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Inclusion Criteria:
Participants (Ps)
Caregiver/Administrators (As)
Exclusion Criteria:
Participants (Ps)
Caregiver/Administrators (As)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HomeStim Study | Contact | 617-971-5416 | homestim@hsl.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alvaro Pascual-Leone, MD; PhD | Hebrew SeniorLife | Principal Investigator |
| Brad Manor, PhD | Hebrew SeniorLife | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hinda and Arthur Marcus Institute for Aging Research | Recruiting | Boston | Massachusetts | 02131 | United States |
The prospective plan is to have data available in a data dementia-related data repository.
This is a multi-year study and the data will be available at the finish, when the data is unblinded.
Depending on the repositories in which the data is held. However, use of the data will be restricted by permission and appropriate human subjects review of the prospective project.
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Randomized, sham-controlled, double-blinded, parallel-arm trial
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Double-blind, sham controlled
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| Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham) | Device | A sham transcranial electrical stimulation (tES) will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex. It will physically mimic active stimulation. |
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| Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham) | Device | Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Active tACS to the left angular gyrus and sham tDCS to the prefrontal cortex. |
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| Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active) | Device | Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Sham tACS to the left angular gyrus and active tDCS to the prefrontal cortex. |
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| baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| Change in Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores | The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. The memory and executive subscales are each on a range of 0 to 5 points. | baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| Average E-field normal component (En) for left angular gyrus and prefrontal cortex | From magnetic resonance imaging, an E-field normal component value will be computer for each brain voxel. From those measurements an average En value will be computed in the anatomically-defined left AG (i.e., Brodmann areas 39/40), and separately the left PFC (i.e., Brodmann areas 39/40). This outcome of average En will provide information on the amount of current each participant receives during the intervention in the targeted areas. | immediate post-intervention |
| Change in Adjusted Trail Making Test performance | The Trail Making Test (TMT) is a test of visual attention and task switching, which consists of two parts (A & B). It is scored by timing how long it takes to complete each part of the test, separately. The maximum time allowed for part A or part B is 300 seconds. Age and education adjusted norms are available to determine standard scores. The Adjusted performance is calculated by subtracting the time it takes to complete part A (in seconds) from the time it takes (in seconds) to complete part B. This is a measure of executive functioning and also has age and education adjusted norms. | baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| Change in Stroop test response latency | The Stroop test assess the participant's ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. The outcome of response latencies, specifically, measures the average reaction time (in milliseconds) of the participant to a) the congruent trials (colors match words) and b) the incongruent trials (colors do not match words). The average difference between congruent and incongruent response latencies will be examined. | baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| Change in Gait speed | The speed of the participants gait during both a) normal walking and b) walking while counting backwards. The speed is measured by the software, Mobility Lab, which is gathered via sensor. Average gait speed varies by age and education. | baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| Change in Stride time variability | This is measured by the software, Mobility Lab, which is gathered via sensor as the participant is walking. The average stride time varies by age and education and is the coefficient of variation of stride times during a normal walk on a straight path. | baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| Change in Short Physical Performance Battery total score | This is an assessment of lower extremity function, and combines results of gait speed, chair stand and balance tests. The range of scores is from 0 to 12, with higher scores indicating better lower extremity functioning. | baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| Change in 12-item Short Form Health Survey (SF-12) | The Short Form - 12 is a measure of health-related quality of life. There are 12 items with responses either from 1 to 3 or 1 to 5 on a Likert-type scale. Standardized scores are calculated for a physical component summary (PCS) and a mental component summary (PCS), with an average of 50 and a standard deviation of 10 and higher scores with better functioning. | baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| Change in Average daily step count | An average daily step count will be computed from data collected through an activity monitor over a 7-day period. The average of the 7 days will be computed for an average daily step count. | baseline, immediate post-intervention, 3 month follow up, 6 month follow up |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D008569 | Memory Disorders |
| D000544 | Alzheimer Disease |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
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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 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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