Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

NCT05904132 | Recruiting DMC FDA Device

• 1 other identifier: 2023P000785
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Changes in the power of entrainment of natural gamma rhythms in patients with AD-MCI.

  Measured using closed loop 40 Hertz tACS device

  After a single stimulation session (30 minutes).

• Changes in cognitive performance in patients with AD-MCI.

  Measured using Rey Auditory Verbal Learning Task (RAVLT) which is broken into 6 blocks with each block including a list of 15 words and higher word remembrance in each block indicates a better outcomes, and Face-Name Association Task (FNAT) task where a higher score of matching face to name (out of 60 trials) indicates a better outcome

  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]

  Measured using Rey Auditory Verbal Learning Task (RAVLT) which is broken into 6 blocks with each block including a list of 15 words and higher word remembrance in each block indicates a better outcomes, and Face-Name Association Task (FNAT) task where a higher score of matching face to name (out of 60 trials) indicates a better outcome, any MRI/PET scans provided prior to study involvement, and changes in gamma power using closed loop 40 Hertz tACS device

  After a single stimulation session (30 minutes).

Study Arms (2)

Healthy Controls

PLACEBO COMPARATOR

Device: tACS device

MCI Subjects

EXPERIMENTAL

Device: tACS device

Interventions

tACS device 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

Healthy Controls; MCI Subjects

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely due to AD (AD biomarker supported)
• years of age
• English native speakers

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Joan Camprodon, MD, PhD, MPH

  MGH, Division of Neuropsychiatry and Neuromodulation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DNN Inbox

CONTACT

6177265348; mghdnn@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Neuropsychiatry and Neuromodulation

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 15, 2023
• Study Start: January 31, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)