Clinical trial NCT04294888: TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory
Official title: TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Aging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Paired Associative Face Name Memory Test
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Changes in intrinsic functional connectivity
timeFrame: up to 5 weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachuetts General Hospital
state: Massachusetts
Study officials:
References: