Back to resultsNon-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia (ACDCStim)
Primary Purpose
Dementia, Memory Loss, Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)
Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham)
Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)
Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active)
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Alzheimer's Disease, Dementia, Memory, Brain Stimulation, transcranial alternating current stimulation (tACS), transcranial direct current stimulation (tDCS), Executive function, instrumental activities of daily living (IADL)
Eligibility Criteria
Inclusion Criteria: Participants (Ps) willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements an informed consent form was signed able to read, write, and communicate in English able to identify an eligible administrator to participate with them in the study Caregiver/Administrators (As) at least 21 years of age able to read, write, and communicate in English self-reported computer proficiency and willingness to learn how to use tES as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tES?" stated availability during weekdays throughout the study period to administer tES to the Ps Exclusion Criteria: Participants (Ps) major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis blindness or other disabilities that prevent task performance contraindications to tES, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, etc.) the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen an inability to understand study procedures following review of the Informed Consent form Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator Caregiver/Administrators (As) mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen insufficient understanding of study procedures following review of the Informed Consent form Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator. poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tES
Sites / Locations
- Hinda and Arthur Marcus Institute for Aging ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Sham Comparator
Arm Label
tACS(AG) + tDCS(PFC) combo active
tACS(AG) active + tDCS(PFC) sham
tACS(AG) sham + tDCS(PFC) active
tACS(AG) sham + tDCS(PFC) sham
Arm Description
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).
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).
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).
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).
Outcomes
Primary Outcome Measures
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.
Change in Dual Task Cost to Gait
This measure is captured by Mobility Lab™ (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.
Secondary Outcome Measures
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:
Dependent = 3
Requires assistance = 2
Has difficulty but does by self = 1
Normal = 0
Never did [the activity] but could do now = 0
Never did and would have difficulty now = 1
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05661084
First Posted
August 25, 2022
Last Updated
April 2, 2023
Sponsor
Hebrew SeniorLife
Collaborators
BrightFocus Foundation, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05661084
Brief Title
Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia
Acronym
ACDCStim
Official Title
Multifocal Transcranial Current Stimulation for Cognitive and Motor Dysfunction in Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebrew SeniorLife
Collaborators
BrightFocus Foundation, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Memory Loss, Alzheimer Disease, Executive Dysfunction, Mobility Limitation
Keywords
Alzheimer's Disease, Dementia, Memory, Brain Stimulation, transcranial alternating current stimulation (tACS), transcranial direct current stimulation (tDCS), Executive function, instrumental activities of daily living (IADL)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, sham-controlled, double-blinded, parallel-arm trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind, sham controlled
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tACS(AG) + tDCS(PFC) combo active
Arm Type
Experimental
Arm Description
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).
Arm Title
tACS(AG) active + tDCS(PFC) sham
Arm Type
Active Comparator
Arm Description
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).
Arm Title
tACS(AG) sham + tDCS(PFC) active
Arm Type
Active Comparator
Arm Description
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).
Arm Title
tACS(AG) sham + tDCS(PFC) sham
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)
Other Intervention Name(s)
Transcranial electrical stimulation (tES)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham)
Other Intervention Name(s)
Transcranial electrical stimulation (sham condition)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)
Other Intervention Name(s)
tACS active; tDCS sham
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active)
Other Intervention Name(s)
tACS sham; tDCS active
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall
Description
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up , 6 month follow up
Title
Change in Dual Task Cost to Gait
Description
This measure is captured by Mobility Lab™ (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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Secondary Outcome Measure Information:
Title
Change in Functional Activity Questionnaire
Description
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:
Dependent = 3
Requires assistance = 2
Has difficulty but does by self = 1
Normal = 0
Never did [the activity] but could do now = 0
Never did and would have difficulty now = 1
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Title
Change in Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
Description
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Title
Average E-field normal component (En) for left angular gyrus and prefrontal cortex
Description
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.
Time Frame
immediate post-intervention
Title
Change in Adjusted Trail Making Test performance
Description
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Title
Change in Stroop test response latency
Description
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Title
Change in Gait speed
Description
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Title
Change in Stride time variability
Description
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Title
Change in Short Physical Performance Battery total score
Description
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Title
Change in 12-item Short Form Health Survey (SF-12)
Description
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Title
Change in Average daily step count
Description
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.
Time Frame
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants (Ps)
willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
able and willing to comply with all study requirements
an informed consent form was signed
able to read, write, and communicate in English
able to identify an eligible administrator to participate with them in the study
Caregiver/Administrators (As)
at least 21 years of age
able to read, write, and communicate in English
self-reported computer proficiency and willingness to learn how to use tES as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tES?"
stated availability during weekdays throughout the study period to administer tES to the Ps
Exclusion Criteria:
Participants (Ps)
major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
blindness or other disabilities that prevent task performance
contraindications to tES, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, etc.)
the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen
an inability to understand study procedures following review of the Informed Consent form
Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator
Caregiver/Administrators (As)
mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen
insufficient understanding of study procedures following review of the Informed Consent form
Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tES
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HomeStim Study
Phone
617-971-5416
Email
homestim@hsl.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvaro Pascual-Leone, MD; PhD
Organizational Affiliation
Hebrew SeniorLife
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brad Manor, PhD
Organizational Affiliation
Hebrew SeniorLife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hinda and Arthur Marcus Institute for Aging Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvaro Pascual-Leone, MD; PhD
First Name & Middle Initial & Last Name & Degree
Maggie Syme, PhD
Phone
617-971-5338
Email
maggiesyme@hsl.harvard.edu
First Name & Middle Initial & Last Name & Degree
Davide Cappon, PhD
First Name & Middle Initial & Last Name & Degree
Brad Manor, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The prospective plan is to have data available in a data dementia-related data repository.
IPD Sharing Time Frame
This is a multi-year study and the data will be available at the finish, when the data is unblinded.
IPD Sharing Access Criteria
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.
Learn more about this trial
Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia
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