NCT04289402|Active Not Recruiting
Individualized Brain Stimulation to Improve Mobility in Alzheimer's Disease
ISTIM-AD
Modulating Brain Activity to Improve Cognitive-motor Function in Alzheimer's Disease
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ISTIM-AD
Modulating Brain Activity to Improve Cognitive-motor Function in Alzheimer's Disease
Sponsor study identifier
interventional
11
1 country
1
Study Start
January 31, 2020
Actual (reported)Primary Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The objective of this study is to conduct a pilot, randomized sham-controlled trials to determine the feasibility and effects of a 10-session personalized tDCS intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in 24 older adults with mild AD living in supportive housing.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2020
Actual (reported)February 13, 2020
Actual (reported)February 28, 2020
Actual (reported)January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Recruitment efficiency
The number of residents that need to be screened in order to enroll one participant into the trial.
1 year
Retention
The percentage of enrolled participants who complete the trial.
1 year
Blinding
A blinding efficacy questionnaire will be used to record participant guesses of their assigned intervention (real or placebo), as well as the confidence of these guesses on a scale from 1=Not confident to 10=Extremely confident.
Immediately after intervention
Montreal Cognitive Assessment (MoCA) total score
This common test assesses global cognitive function. Maximum score on the MoCA is 30 points (minimum = 0), with higher scores associated with better outcomes.
Change from baseline to two-week follow-up
Trail making test A-B
Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Digit Span
Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Digit Symbol Substitution Test
Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Category and Phonemic Fluency Test
Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Hopkins Verbal Learning Test
Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Baseline MRIs will enable personalization of tDCS via current flow modeling for optimization to each participant with the goal of generating an average electric field of 0.25 V/m within their identified left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA. Each 20-minutes session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
The participant will receive 10, 20-minutes sessions of personalized tDCS Monday-Friday, at approximately the same time of day, over two consecutive weeks.
The participant will receive 20, 20-minute sessions of active-sham stimulation Monday-Friday, at approximately the same time of day, over two consecutive weeks.
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131, United States
Brad Manor, PhD
Hebrew SeniorLife
11 participants (actual enrollment reported by the registry).
Effects of Exercise and Cognitive Training on Cognitive Function in Older Adults
Dual task gait speed
This metric assesses the ability to control gait while performing a secondary cognitive task.
Change from baseline to two-week follow-up
Dual task standing postural sway area
This metric assesses the ability to control standing posture while performing a secondary cognitive task.
Change from baseline to two-week follow-up
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Submitted
February 13, 2020
First Posted
February 28, 2020
Study Start
January 31, 2020
Actual (reported)Primary Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 27, 2026
Record last verified: 2026-04
The HSL Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, physiologic, and brain imaging data, from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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