Print

Purpose

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]

Conditions

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Healthy Controls
  • 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
Experimental
MCI Subjects
  • 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

Recruiting Locations

Massachusetts General Hospital
Charlestown, Massachusetts 02129
Contact:
Joan Camprodon, MD, MPH, PhD

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

DNN Inbox
6177265348
mghdnn@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.