Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05904132
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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]

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Mild Cognitive Impairment	Device: tACS device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Healthy Controls	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
Experimental: MCI Subjects	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

Outcome Measures

Primary Outcome Measures

1. Changes in the power of entrainment of natural gamma rhythms in patients with AD-MCI. [After a single stimulation session (30min).]

   Measured using closed loop 40 Hz tACS device

2. Changes in cognitive performance in patients with AD-MCI. [After a single stimulation session (30min).]

   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

3. Changes in gamma power on cognition in patients with AD-MCI including the effect of baseline neurodegenerative burden/biomarkers. [exploratory] [After a single stimulation session (30min).]

   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 Hz tACS device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Charlestown	Massachusetts	United States	02129

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Joan Camprodon, MD, PhD, MPH, MGH, Division of Neuropsychiatry and Neuromodulation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joan A Camprodon, MD MPH PhD, Chief, Division of Neuropsychiatry and Neuromodulation, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05904132
• Other Study ID Numbers: 2023P000785
• First Posted: Jun 15, 2023
• Last Update Posted: Jun 15, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Alzheimer Disease; Cognitive Dysfunction

Study Results

No Results Posted as of Jun 15, 2023