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NCT Number: NCT06956300

TMS for Cognitive Decline in Aging and Preclinical AD

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.

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Key information

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location status: Recruiting

Location contact

Alexandra Touroutoglou, MSc, PhD

CONTACT

[email protected]

617-643-6348

Alexandra Touroutoglou, MSc, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active rTMS

Device

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).

sham rTMS

Device

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 outcomes

  1. Changes in motivation

    Time frame: Baseline and post-treatment Day 11

    This will be measured by ratings of grit on a 5-point scale using the Grit Scale (Duckworth, et al., 2007).

  2. Changes in Brain Network Connectivity

    Time frame: Baseline and post-treatment Day 11

    This will include changes in resting-state functional connectivity measured with functional Magnetic Resonance Imaging (fMRI)

  3. Changes in Memory

    Time frame: Baseline and Post-Treatment Day 11

    This will be measured with an associative memory task

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Touroutoglou, PhD

CONTACT

[email protected]

6176436348

Jordan Walter, BA

CONTACT

[email protected]

6177266207

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 4, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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