RECRUITING

TMS for Cognitive Decline in Aging and Preclinical AD

Conditions

Prodromal Alzheimer's Disease Preclinical Alzheimer's Disease Healthy Aging Cognitive Decline Transcranial Magnetic Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this research study we want to learn more about the effects of non-invasive brain stimulation on motivation, memory, and brain-network function in cognitively unimpaired older adults and individuals with preclinical Alzheimer's disease. This study will use a form of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will slightly alter activity in an area of your brain that controls cognition. Changes resulting from this stimulation will be measured with behavioral tests, as well as by taking brain images with Magnetic Resonance Imaging (MRI). Participants will come in for one baseline visit followed by 10 days of daily rTMS study visits (Monday through Friday) and an evaluation visit. Then, there will be a 2-week break. After this break, they will return for another baseline visit, an additional 10 days of rTMS, and a final evaluation visit.

Official Title

Grit Against Cognitive Decline in Aging and Preclinical Alzheimer's Disease

Quick Facts

Study Start:2025-04-07

Study Completion:2029-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06956300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Between the ages of 40-99 2. Native English speakers 3. Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points 4. Cognitively normal older adults and individuals with preclinical Alzheimer's disease will be included.	1. History of head trauma involving loss of consciousness or alteration in consciousness 2. Another major neurologic or psychiatric condition 3. Known presence of a structural brain lesion (e.g. tumor, cortical infarct) 4. Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body 5. 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 6. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol. 7. Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging 8. History of unprovoked seizures (i.e., seizures that occur in the absence of a clear provocation such as hyponatremia, hypoglycemia, etc.). 9. Subjects who have a first degree relative (e.g., father, mother or sibling) with a seizure disorder. 10. Subjects currently taking, or plan to take, medications which are highly epileptogenic. These include: clozapine, high doses of bupropion (i.e., greater than 400mg daily), diphenhydramine, cyclosporine, isoniazid, imipenem, chloroquine, tramadol and theophylline.

Inclusion Criteria

Exclusion Criteria

1. Between the ages of 40-99
2. Native English speakers
3. Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points
4. Cognitively normal older adults and individuals with preclinical Alzheimer's disease will be included.

1. History of head trauma involving loss of consciousness or alteration in consciousness
2. Another major neurologic or psychiatric condition
3. Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
4. Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
5. 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
6. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.
7. Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging
8. History of unprovoked seizures (i.e., seizures that occur in the absence of a clear provocation such as hyponatremia, hypoglycemia, etc.).
9. Subjects who have a first degree relative (e.g., father, mother or sibling) with a seizure disorder.
10. Subjects currently taking, or plan to take, medications which are highly epileptogenic. These include: clozapine, high doses of bupropion (i.e., greater than 400mg daily), diphenhydramine, cyclosporine, isoniazid, imipenem, chloroquine, tramadol and theophylline.

Contacts and Locations

Study Contact

Alexandra Touroutoglou, PhD

CONTACT

6176436348

atouroutoglou@mgh.harvard.edu

Anna Du, BA

CONTACT

6176436348

andu@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02129

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-07

Study Completion Date2029-08-31

Study Record Updates

Study Start Date2025-04-07

Study Completion Date2029-08-31

Terms related to this study

Keywords Provided by Researchers

Transcranial Magnetic Stimulation

Additional Relevant MeSH Terms

Prodromal Alzheimer's Disease
Preclinical Alzheimer's Disease
Healthy Aging
Cognitive Decline