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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

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

Be older than 65 years old

Must not have

Clinical history of stroke, Parkinson's disease, parkinsonian symptoms, multiple sclerosis, normal pressure hydrocephalus, or other neurological conditions outside of mild AD

Inability to ambulate without the assistance of another person (canes or walkers allowed)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild Alzheimer's with some memory loss and daily activity challenges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of neurological conditions other than mild Alzheimer's Disease.

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I need someone's help to walk, but I can use a cane or walker.

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I have severe depression based on a specific depression scale score.

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I have been diagnosed with schizophrenia, bipolar disorder, or another psychiatric condition.

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I have severe arthritis in my legs or diagnosed nerve damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blinding

Dual task gait speed

Dual task standing postural sway area

+3 more

Secondary study objectives

Category and Phonemic Fluency Test

Centers for Epidemiologic Studies Depression Scale

Digit Span

+7 more

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.

0 / 6Eligibility criteria met