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Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

NCT05904132 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-06-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Joan Camprodon, MD, PhD, MPH · MGH, Division of Neuropsychiatry and Neuromodulation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05904132 on ClinicalTrials.gov