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TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory

TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04294888
Enrollment
4
Registered
2020-03-04
Start date
2020-03-02
Completion date
2021-06-23
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Alzheimer Disease, Mild Cognitive Impairment

Brief summary

The purpose of this study is to assess the effects of non-invasive brain stimulation on memory in cognitively unimpaired older adults and in patients amnestic mild cognitive impairment (aMCI) due to Alzheimer's disease (AD). This study will use repetitive Transcranial Magnetic Stimulation (rTMS) to stimulate nodes of the Default Mode Network (DMN)- which is thought to support episodic memory and to be affected by Alzheimer's pathology. We will use functional connectivity MRI (fcMRI) to assess changes in functional network architecture following the stimulation. We will also assess putative cognitive improvements resulting from the stimulation by in-depth memory testing.

Interventions

DEVICErepetitive transcranial magnetic stimulation (rTMS)

rTMS is a method to focally and reversibly stimulate a pre-specified cortical target. rTMS works through the principle of electromagnetic induction.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

All participants will undergo SHAM stimulation as a control condition. They will be blinded as to whether they are receiving active or SHAM stimulation.

Intervention model description

Participants will each undergo, in a crossover, within-subject design, two blocks of rTMS: active and SHAM.The order of active and SHAM blocks will be counterbalanced across subjects.

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

1. Between the ages of 60-85 2. All participants will be native English speakers 3. Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points 4. Participants with aMCI will be asked to bring a study partner to all visits 5. Only patients with very mild or mild cognitive impairment (CDR 0.5 or CDR 1) will be included in the prodromal AD cohort

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Paired Associative Face Name Memory Testup to 5 weeksA test of memory for face-name associations

Secondary

MeasureTime frameDescription
Changes in intrinsic functional connectivityup to 5 weeksChanges in region-to-region functional connectivity within the stimulated network will be assessed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026