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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).
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ after a single stimulation session (30 minutes).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after a single stimulation session (30 minutes).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
2,928 Previous Clinical Trials
13,198,285 Total Patients Enrolled
Joan Camprodon, MD, PhD, MPHPrincipal InvestigatorMGH, Division of Neuropsychiatry and Neuromodulation
5 Previous Clinical Trials
914 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosed brain lesion, such as a tumor.I do not have any worsening or uncontrolled health conditions.I have an active blood, kidney, lung, hormone, or liver disorder.I don't have scalp lesions or a history of seizures.I have mild memory problems likely due to Alzheimer's, confirmed by tests.I am between 50 and 80 years old.I am a native English speaker.
Research Study Groups:
This trial has the following groups:- Group 1: MCI Subjects
- Group 2: Healthy Controls
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment include individuals over the age of forty-five as participants?
"To be included in this experiment, participants must fall within the 50 to 80 year-old age bracket. There are 42 studies involving minors and 961 for those above retirement age."
Answered by AI
Are new enrollees still being accepted for this trial?
"As per clinicaltrials.gov, this medical trial is not presently seeking new participants; the original posting date was on July 1st 2023 and last edited June 6th 2023. However, there are an abundance of other trials actively recruiting with a total of 1007 studies at present."
Answered by AI
Are there any qualifications for potential participants in this research?
"Eligible candidates for this clinical trial must be between the ages of 50 and 80, have a confirmed diagnosis of Alzheimer's disease, and join a cohort size of approximately 70."
Answered by AI
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