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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04294888
• Other study ID #: 2019P003445
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2020
• Source: Massachusetts General Hospital
• Contact: Jessica A Collins, PhD
• Phone: 617-726-6217
• Email: jcollins21[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• repetitive 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.

Locations

Country	Name	City	State
United States	Massachuetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paired Associative Face Name Memory Test	A test of memory for face-name associations	up to 5 weeks
Secondary	Changes in intrinsic functional connectivity	Changes in region-to-region functional connectivity within the stimulated network will be assessed	up to 5 weeks