Recruiting

tACS

Sponsor:

Massachusetts General Hospital

Code:

NCT05904132

Conditions

Alzheimer Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

tACS device

Study Details

Brief summary:

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

Alzheimer Disease

Mild Cognitive Impairment

Study ID

NCT05904132

Start date

Jan 31, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Healthy Controls

experimental: MCI Subjects

Interventions

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 measure

  • 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). ]

Central Contacts and Locations

Central contacts

DNN Inbox

6177265348mghdnn@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

6177265348jcamprodon@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 14, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-14.