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Neuromodulation for Depression and Memory Loss in Older Adults
N/A
Recruiting
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
Must not have
Contraindications to tES, as recorded on a standardized screening questionnaire, which include specific medical conditions and use of neuroactive drugs
Blindness or other disabilities that prevent task performance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline demqol at 3 month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to explore if brain stimulation therapy can help relieve mood & memory symptoms in older adults with depression & dementia.
Who is the study for?
This trial is for older adults with major depressive disorder and dementia who can follow the study's rules, communicate in English, and have a caregiver over 21 years old to help. Participants must be able to see well enough and not have severe arthritis or skin conditions on the scalp that could interfere with treatment.
What is being tested?
The trial tests home-based brain stimulation therapies—transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS)—to improve mood and memory symptoms in older adults suffering from depression within the context of dementia.
What are the potential side effects?
Potential side effects may include discomfort at the site of electrode placement, itching, tingling during the session, fatigue, headache, nausea or insomnia. These are usually mild and temporary.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't have conditions or take medications that would make tES unsafe for me.
Select...
I am unable to perform tasks due to blindness or other disabilities.
Select...
I have an active skin condition like eczema on my scalp.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline gds-15 total score at 3 months follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline gds-15 total score at 3 months follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Altman Self-Rating Mania Scale (ASRM)
Category and Phonemic Fluency Test
Cornell Scale for Depression in Dementia (CSDD)
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of ADExperimental Treatment1 Intervention
Participants will undergo 20 sessions of home-based tDCS over the prefrontal cortex and tACS over the left angular gyrus.These sessions will take place five times a week for four weeks, with one daily stimulation session of no more than 20 minutes. The participant's home will be the setting for the completion of the brain stimulation intervention, which will be delivered by trained caregivers/study companions/administrators.
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Who is running the clinical trial?
Hebrew SeniorLifeLead Sponsor
47 Previous Clinical Trials
272,282 Total Patients Enrolled
Brain & Behavior Research FoundationOTHER
62 Previous Clinical Trials
2,901 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My caregiver is at least 21 years old.I don't have conditions or take medications that would make tES unsafe for me.My caregiver is available on weekdays to help with my treatment.You scored 18 or lower on the Montreal Cognitive Assessment (MoCA) during the in-person screening.You have slight problems with memory and thinking, as measured by a test called MoCA with a score of 26 or lower during a face-to-face evaluation.I have a condition like poor eyesight or severe arthritis that makes it hard for me to manage treatments on my own.I understand the study details and agree to participate.I am unable to perform tasks due to blindness or other disabilities.I have an active skin condition like eczema on my scalp.
Research Study Groups:
This trial has the following groups:- Group 1: tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.