TMS for Cognitive Decline in Aging and Preclinical AD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active rTMS, Sham rTMS.
- Who it may be relevant to
- Registry conditions: Prodromal Alzheimer's Disease, Preclinical Alzheimer's Disease, Healthy Aging, Cognitive Decline. Basic parameters: 40 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Grit Against Cognitive Decline in Aging and Preclinical Alzheimer's Disease
Overview
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.
Interventions
- Device Active rTMS
All study participants will receive one block of ACTIVE rTMS. Each block will consist of daily sessions of active rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday). - Device Sham rTMS
All study participants will receive one block of SHAM rTMS. Each block will consist of daily sessions of SHAM rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday).
Primary outcome measures
- Changes in motivation [Time frame: Baseline and post-treatment Day 11]
- Changes in Brain Network Connectivity [Time frame: Baseline and post-treatment Day 11]
- Changes in Memory [Time frame: Baseline and Post-Treatment Day 11]
Eligibility criteria
Inclusion criteria
- Between the ages of 40-99
- Native English speakers
- Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points
- Cognitively normal older adults and individuals with preclinical Alzheimer's disease will be included.
Exclusion criteria
- History of head trauma involving loss of consciousness or alteration in consciousness
- Another major neurologic or psychiatric condition
- Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
- 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
- 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
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.
- Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging
- History of unprovoked seizures (i.e., seizures that occur in the absence of a clear provocation such as hyponatremia, hypoglycemia, etc.).
- Subjects who have a first degree relative (e.g., father, mother or sibling) with a seizure disorder.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT06956300 · 2023A009489