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Brain Stimulation

Brain Stimulation for Alzheimer's Disease (ISTIM-AD 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
Men and women aged 65 and older living within supportive housing facilities
Mild Alzheimer's disease (AD) defined by the combination of at least mild cognitive impairment, informant-report of Instrumental Activities of Daily Living impairment, and a Clinical Dementia Rating score of 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

ISTIM-AD Trial Summary

This trial will test if a brain stimulation intervention can help improve cognitive function, mobility, and other measures in older adults with mild Alzheimer's disease.

Who is the study for?
This trial is for men and women aged 65 or older with mild Alzheimer's, living in supportive housing. Participants must have some cognitive impairment, difficulty with daily activities, and a specific dementia rating. Excluded are those with MRI or tDCS contraindications like seizures, metal in the body, certain medical devices, skin conditions on the scalp; also excluded are those unable to walk without help (except cane/walker users), severe arthritis/neuropathy sufferers, other neurological condition patients outside of mild AD.Check my eligibility
What is being tested?
The study tests a brain stimulation technique called personalized tDCS aimed at improving cognitive function and mobility in Alzheimer's patients. It involves 10 sessions targeting the left prefrontal cortex compared against a sham (placebo-like) procedure to see if there's any benefit.See study design
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site on the scalp, itching or tingling during stimulation, fatigue after treatment sessions, headache or nausea. However as this is a pilot study these side effects will be closely monitored.

ISTIM-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 65 or older and live in a supportive housing facility.
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I have mild Alzheimer's with some memory loss and daily activity challenges.

ISTIM-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blinding
Dual task gait speed
Dual task standing postural sway area
+3 more
Secondary outcome measures
Category and Phonemic Fluency Test
Centers for Epidemiologic Studies Depression Scale
Digit Span
+7 more

ISTIM-AD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Personalized tDCSExperimental Treatment1 Intervention
Baseline MRIs will enable personalization of tDCS via current flow modeling for optimization to each participant with the goal of generating an average electric field of 0.25 V/m within their identified left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA. Each 20-minutes session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Group II: Active-ShamPlacebo Group1 Intervention
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.

Find a Location

Who is running the clinical trial?

Hebrew SeniorLifeLead Sponsor
45 Previous Clinical Trials
270,532 Total Patients Enrolled
Brad Manor, PhDPrincipal Investigator - Hebrew SeniorLife
Hebrew SeniorLife
5 Previous Clinical Trials
403 Total Patients Enrolled

Media Library

Personalized tDCS (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04289402 — N/A
Alzheimer's Disease Research Study Groups: Personalized tDCS, Active-Sham
Alzheimer's Disease Clinical Trial 2023: Personalized tDCS Highlights & Side Effects. Trial Name: NCT04289402 — N/A
Personalized tDCS (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04289402 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacant positions in this clinical trial?

"Affirmative. Information hosted on clinicaltrials.gov reflects that this medical trial is actively seeking patients for enrolment. This initiative was first posted in January 2021 and most recently updated in March 2022; it requires 24 participants from a single site."

Answered by AI

What objectives does this experiment seek to accomplish?

"The primary goal of this clinical trial, to be measured over two weeks, is to evaluate dual task standing postural sway area. Secondary objectives include assessing mobility with the Timed Up-and-Go test and quantifying habitual physical activity and postural control while performing a cognitive task through Five-day accelerometry-based physical activity and Dual Task Standing Postural Sway Speed tests respectively."

Answered by AI

What is the aggregate patient count for this clinical trial?

"Affirmative. The clinical trial registry states that this research initiative is actively searching for subjects. It was first listed on January 31st 2020 and the latest update occurred on March 14th 2022. 24 individuals are being sought from one medical facility."

Answered by AI
~0 spots leftby May 2024