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Device

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 in category and phonemic fluency test 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:
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I don't have conditions or take medications that would make tES unsafe for me.
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I am unable to perform tasks due to blindness or other disabilities.
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I have an active skin condition like eczema on my scalp.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline gds-15 total score at 3 months follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline gds-15 total score at 3 months follow-up for reporting.

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 more

Awards & 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
46 Previous Clinical Trials
270,729 Total Patients Enrolled
4 Trials studying Depression
64 Patients Enrolled for Depression
Brain & Behavior Research FoundationOTHER
62 Previous Clinical Trials
2,901 Total Patients Enrolled
20 Trials studying Depression
1,145 Patients Enrolled for Depression

Media Library

Transcranial alternating current stimulation (tACS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05976659 — N/A
Depression Research Study Groups: tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD
Depression Clinical Trial 2023: Transcranial alternating current stimulation (tACS) Highlights & Side Effects. Trial Name: NCT05976659 — N/A
Transcranial alternating current stimulation (tACS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05976659 — N/A
~2 spots leftby Jan 2025