Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06538311

Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease

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 amnestic mild cognitive impairment (aMCI).

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 memory. Changes resulting from this stimulation will be measured with behavioral tests of memory and general cognition, as well as by taking images of your brain 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location status: Recruiting

Location contact

Alexandra Touroutoglou, PhD

CONTACT

[email protected]

Alexandra Touroutoglou, 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
  • 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 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.
  • 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.

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 Memory

    Time frame: Baseline and post-treatment Day 11

    This will include observed changes in memory as a result of the stimulation through neuropsychological testing.

  2. Changes in Brain Network Connectivity

    Time frame: Baseline and post-treatment Day 11

    This will include observed changes in resting-state functional connectivity as a result of the stimulation.

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

Neuromodulation of Brain Function in Alzheimer's Disease and Related Dementias

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2024
Registry last updated
May 6, 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.

Published trials that share one or more normalized conditions with this study.