Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia
ACDCStim
Multifocal Transcranial Current Stimulation for Cognitive and Motor Dysfunction in Dementia
2 other identifiers
interventional
144
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2022
CompletedFirst Posted
Study publicly available on registry
December 22, 2022
CompletedStudy Start
First participant enrolled
January 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
January 12, 2026
January 1, 2026
3.9 years
August 25, 2022
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (10)
Change in Functional Activity Questionnaire
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
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
immediate post-intervention
Change in Adjusted Trail Making Test performance
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Stroop test response latency
baseline, immediate post-intervention, 3 month follow up, 6 month follow up
- +5 more secondary outcomes
Study Arms (4)
tACS(AG) + tDCS(PFC) combo active
EXPERIMENTALParticipants (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).
tACS(AG) active + tDCS(PFC) sham
ACTIVE COMPARATORParticipants (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).
tACS(AG) sham + tDCS(PFC) active
ACTIVE COMPARATORParticipants (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).
tACS(AG) sham + tDCS(PFC) sham
SHAM COMPARATORParticipants (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).
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- Caregiver/Administrators (As)
- at least 18 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hebrew SeniorLifelead
- BrightFocus Foundationcollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Hinda and Arthur Marcus Institute for Aging Research
Boston, Massachusetts, 02131, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alvaro Pascual-Leone, MD; PhD
Hebrew SeniorLife
- PRINCIPAL INVESTIGATOR
Brad Manor, PhD
Hebrew SeniorLife
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind, sham controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2022
First Posted
December 22, 2022
Study Start
January 24, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- This is a multi-year study and the data will be available at the finish, when the data is unblinded.
- 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.
The prospective plan is to have data available in a data dementia-related data repository.