Status:

RECRUITING

Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Alzheimer Disease

Mild Cognitive Impairment

Eligibility:

All Genders

40-99 years

Phase:

EARLY_PHASE1

Brief Summary

In this research study we want to learn more about the effects of non-invasive brain stimulation on memory and brain-network function in cognitively unimpaired older adults and in patients with amnest...

Eligibility Criteria

Inclusion

  • 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
  • Patients with PPA will be asked to bring a study partner to all visits
  • Patients with very mild or mild PPA, patients with amnestic mild cognitive impairment and cognitively unimpaired participants with preclinical AD will be included.

Exclusion

  • 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.
  • Subjects actively on anti-amyloid treatments. This is because they are at risk for bleeding due to amyloid-related imaging abnormalities (ARIA) that could provoke seizures.

Key Trial Info

Start Date :

May 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06538311

Start Date

May 1 2023

End Date

March 31 2026

Last Update

April 2 2025

Active Locations (1)

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1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02129