- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06538311
Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease
Neuromodulation of Brain Function in Alzheimer's Disease and Related Dementias
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Alexandra Touroutoglou, PhD
- Phone Number: 6176436348
- Email: atouroutoglou@mgh.harvard.edu
Study Contact Backup
- Name: Jordan Walter, BA
- Phone Number: 6177266207
- Email: jwalter2@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02129
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Alexandra Touroutoglou, PhD
- Email: atouroutoglou@mgh.harvard.edu
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Principal Investigator:
- Alexandra Touroutoglou, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AD, aMCI, lvPPA patients, and preclinical AD
All participants will receive the same study interventions in a within-subject crossover design.
|
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).
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and post-treatment Day 11
|
|
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.
|
Baseline and post-treatment Day 11
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900.
- Damoiseaux JS, Prater KE, Miller BL, Greicius MD. Functional connectivity tracks clinical deterioration in Alzheimer's disease. Neurobiol Aging. 2012 Apr;33(4):828.e19-30. doi: 10.1016/j.neurobiolaging.2011.06.024. Epub 2011 Aug 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022A002983
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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