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Non-invasive Brain Stimulation
Non-invasive Brain Stimulation for Dementia (ACDCStim Trial)
N/A
Recruiting
Led By Brad Manor, PhD
Research Sponsored by Hebrew SeniorLife
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Awards & highlights
ACDCStim Trial Summary
This trial will study whether a remote brain stimulation intervention can improve memory, mobility and thinking skills in older adults with mild cognitive problems.
Who is the study for?
This trial is for older adults with mild cognitive impairment or mild dementia who can read, write, and communicate in English. They must have a caregiver willing to learn and administer brain stimulation treatments. Participants should not have severe psychiatric disorders, major vision impairments, skin conditions on the scalp, or score below 18 on the MoCA test.Check my eligibility
What is being tested?
The study tests if remote brain stimulation by caregivers can improve memory, mobility, and executive function in dementia patients. It involves active/sham transcranial direct current (tDCS) and alternating current (tACS) stimulations to see which combination is effective.See study design
What are the potential side effects?
Potential side effects of tDCS/tACS may include discomfort at the electrode site on the scalp, headache, fatigue, nausea or itching during stimulation. Serious side effects are rare but could involve changes in mood or thinking.
ACDCStim Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Dual Task Cost to Gait
Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall
Secondary outcome measures
Average E-field normal component (En) for left angular gyrus and prefrontal cortex
Change in 12-item Short Form Health Survey (SF-12)
Change in Adjusted Trail Making Test performance
+7 moreACDCStim Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: tACS(AG) + tDCS(PFC) combo activeExperimental Treatment1 Intervention
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).
Group II: tACS(AG) active + tDCS(PFC) shamActive Control1 Intervention
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).
Group III: tACS(AG) sham + tDCS(PFC) activeActive Control1 Intervention
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).
Group IV: tACS(AG) sham + tDCS(PFC) shamPlacebo Group1 Intervention
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).
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Who is running the clinical trial?
BrightFocus FoundationOTHER
4 Previous Clinical Trials
284 Total Patients Enrolled
2 Trials studying Dementia
186 Patients Enrolled for Dementia
Hebrew SeniorLifeLead Sponsor
45 Previous Clinical Trials
270,405 Total Patients Enrolled
9 Trials studying Dementia
222,572 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,741 Total Patients Enrolled
268 Trials studying Dementia
23,627,462 Patients Enrolled for Dementia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to consent to participate in the study.I do not have any disabilities that stop me from performing tasks.I do not have any active skin conditions like eczema on my scalp.I, as a caregiver, can use my hands without severe pain, arthritis, or any condition that would prevent me from administering treatments.My caregiver is available on weekdays to help with my treatment.You cannot have a score of 18 or lower on the Montreal Cognitive Assessment (MoCA) test during the in-person screening.My caregiver is at least 21 years old.
Research Study Groups:
This trial has the following groups:- Group 1: tACS(AG) active + tDCS(PFC) sham
- Group 2: tACS(AG) sham + tDCS(PFC) active
- Group 3: tACS(AG) sham + tDCS(PFC) sham
- Group 4: tACS(AG) + tDCS(PFC) combo active
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollment opportunities for this clinical experiment?
"According to the clinicaltrials.gov listing, this trial is not currently recruiting patients. Originally posted on January 31st 2023 and last modified on December 13th 2022, there are no openings at the moment; however, 862 other trials require participants right now."
Answered by AI
What is the purpose of this research endeavor?
"This study's primary outcome of Change in Dual Task Cost to Gait is assessed over baseline, post-intervention and follow up periods at 3 and 6 months. Secondary objectives include evaluating the Change in Montreal Cognitive Assessment total score, memory and executive subscores; Average E-field normal component for left angular gyrus and prefrontal cortex; and Adjusted Trail Making Test performance. This latter measure captures visual attention and task switching ability with age/education adjusted norms applied."
Answered by AI
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