Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tACS device.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Mild Cognitive Impairment. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The project is a placebo-controlled study that aims to use closed-loop transcranial alternating current stimulation (tACS) to study patients with symptoms of mild cognitive impairment which is likely due to Alzheimer's disease or another form of dementia (AD-MCI). Patients will undergo an EEG and complete some questionnaires and computer tasks during each study visit. The project has the following aims and hypotheses: 1.) To determine the impact of closed-loop 40 Hz tACS on the entrainment of natural gamma rhythms in patients with AD-MCI, 2.) To determine the impact of closed-loop 40 Hz tACS on cognitive performance in patients with AD-MCI, and 3.) To assess the relationship between baseline neurodegenerative burden and impact of tACS. \[exploratory\]
Interventions
- Device tACS device
you will receive one of four treatment conditions that include active and sham tACS. The four conditions are the following: (1) closed-loop-tACS (peak-locked), (2) closed-loop-tACS (trough-locked), (3) open-loop tACS, and (4) sham tACS. Although each subject will undergo all four treatments in four separate study visits, the order of the treatments will be randomized
Primary outcome measures
- Changes in the power of entrainment of natural gamma rhythms in patients with AD-MCI. [Time frame: After a single stimulation session (30 minutes).]
- Changes in cognitive performance in patients with AD-MCI. [Time frame: After a single stimulation session (30 minutes).]
- Changes in gamma power on cognition in patients with AD-MCI including the effect of baseline neurodegenerative burden/biomarkers. [exploratory] [Time frame: After a single stimulation session (30 minutes).]
Eligibility criteria
Inclusion criteria
- Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely due to AD (AD biomarker supported)
- 50-80 years of age
- English native speakers
Exclusion criteria
- Known presence of a structural brain lesion (e.g., tumor, cortical infarct)
- Acute or decompensated active medical conditions, including cancer, cardiovascular disease, stroke, congestive heart failure
- Active hematological, renal, pulmonary, endocrine or hepatic disorders
- Longstanding premorbid history (i.e., longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
- tACS contraindications (lesions in the scalp, history of seizures)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Charlestown
Identifiers
NCT: NCT05904132 · 2023P000785