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Neuromodulation Therapy

Closed-Loop Neuromodulation for Alzheimer's Disease

N/A
Waitlist Available
Led By Joan Camprodon, MD, PhD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after a single stimulation session (30 minutes).

Summary

This trial aims to study the effects of an electrical stimulation on Alzheimer's & dementia symptoms, using EEGs, questionnaires & computer tasks. The goal is to understand how it impacts cognitive performance & entrainment of natural rhythms.

Who is the study for?
This trial is for English-speaking adults aged 50-80 with mild cognitive impairment likely due to Alzheimer's, supported by AD biomarkers. It excludes those with brain lesions, acute medical conditions like cancer or heart failure, active major organ disorders, long-term substance abuse history, and contraindications to tACS such as scalp lesions or seizure history.
What is being tested?
The study tests closed-loop transcranial alternating current stimulation (tACS) on patients with Alzheimer's-related mild cognitive impairment. It aims to see if tACS can synchronize natural brain rhythms and improve cognition. Participants will have EEGs and complete tasks during visits in this placebo-controlled study.
What are the potential side effects?
Potential side effects of the tACS device may include discomfort at the electrode sites on the scalp, headache, fatigue or nausea. Since it involves electrical stimulation of the brain, there might be a rare risk of inducing seizures in susceptible individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after a single stimulation session (30 minutes).
This trial's timeline: 3 weeks for screening, Varies for treatment, and after a single stimulation session (30 minutes). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in cognitive performance in patients with AD-MCI.
Changes in gamma power on cognition in patients with AD-MCI including the effect of baseline neurodegenerative burden/biomarkers. [exploratory]
Changes in the power of entrainment of natural gamma rhythms in patients with AD-MCI.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MCI SubjectsExperimental Treatment1 Intervention
Group II: Healthy ControlsPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,316,642 Total Patients Enrolled
Joan Camprodon, MD, PhD, MPHPrincipal InvestigatorMGH, Division of Neuropsychiatry and Neuromodulation
5 Previous Clinical Trials
914 Total Patients Enrolled

Media Library

tACS device (Neuromodulation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05904132 — N/A
Alzheimer's Disease Research Study Groups: MCI Subjects, Healthy Controls
Alzheimer's Disease Clinical Trial 2023: tACS device Highlights & Side Effects. Trial Name: NCT05904132 — N/A
tACS device (Neuromodulation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05904132 — N/A
~28 spots leftby May 2025