Glymphatic Function TMS Study (GF-TMS)

December 10, 2025 updated by: Ying-hui Chou, University of Arizona

Investigating the Impact of Transcranial Magnetic Stimulation (TMS) on Amyloid and Tau Clearance Via Glymphatic Function in Prodromal Alzheimer's Disease

The purpose of this study is to use transcranial magnetic stimulation (TMS) in older adults to impact the glymphatic system. The glymphatic system is a brain-wide clearance pathway that plays a crucial role in removing dysfunctional proteins in Alzheimer's disease. This project aims to investigate if TMS can help glymphatic function and reduce levels of these proteins in those with mild cognitive impairment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Individuals with mild cognitive impairment (MCI Group)

Inclusion Criteria:

  • Age 18-85 years
  • MCI subjective criteria: self- or informant-reported cognitive complaint
  • Objective cognitive impairment supported by one of the following measures of general cognitive function: (a) classified as MCI via the NACC-UDS 3.0 neuropsychological battery using the typical neuropsychological criteria for MCI diagnosis (1 score on any test at least1.5 SD below the mean); or (b) classified as MCI via the NACC-UDS 3.0 neuropsychological battery using the Jak/Bondi neuropsychological criteria for MCI diagnosis(2 scores at least 1 SD below the mean in one domain, or 3 scores at least 1SD below the mean across domains)
  • Right-handed
  • English speaking
  • Able to attend daily intervention and outcome measurements for ~15 days over a 6 month period.
  • Not enrolled in another interventional study within 6 months prior to beginning this study

Exclusion Criteria:

  • Contraindications to transcranial magnetic stimulation (TMS) or magnetic resonance imaging (MRI)
  • Reported sudden or steep decline of cognitive performance
  • Telephone Interview for cognitive impairment (TICS) score
  • Other neurological disorders (e.g., stroke, head injuries, or multiple sclerosis)
  • Psychiatric disorder (except stable late-life depression due to its high prevalence in MCI individuals)
  • Current cancer treatment or other comorbid/unstable medical conditions that might independently affect cognitive function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active (TBS) - Sham (TBS)
Block 1: Active TBS Block 2: Sham TBS
Device: Transcranial Magnetic Stimulation

TMS is a non-invasive brain stimulation technique. The primary aim of the study will be to verify the deliverability of the TMS effect on the hippocampus and determine which stimulation protocol is more beneficial to each participant.

Device: Transcranial Magnetic Stimulation (Sham)

TMS is a non-invasive brain stimulation technique. The primary aim of the study will be to verify the deliverability of the TMS effect on the hippocampus and determine which stimulation protocol is more beneficial to each participant. For sham, the side of the coil that does not deliver pulses will be used.
Experimental: Sham (TBS) - Active (TBS)
Block 1: Sham TBS Block 2: Active TBS
Device: Transcranial Magnetic Stimulation

TMS is a non-invasive brain stimulation technique. The primary aim of the study will be to verify the deliverability of the TMS effect on the hippocampus and determine which stimulation protocol is more beneficial to each participant.

Device: Transcranial Magnetic Stimulation (Sham)

TMS is a non-invasive brain stimulation technique. The primary aim of the study will be to verify the deliverability of the TMS effect on the hippocampus and determine which stimulation protocol is more beneficial to each participant. For sham, the side of the coil that does not deliver pulses will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIH Toolbox
Time Frame: Day 1(baseline for block 1), Day 14(post block 1), Day 70 (Baseline block 2), Day 84 (post block 2)
The NIH Toolbox Cognition Battery, recommended for ages 7+, consists of tests of multiple constructs. It yields individual test scores and the following summary scores: Total Cognition Composite, Fluid Composite (includes Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory (Form A), List Sorting Working Memory, and Pattern Comparison tests), and Crystallized Composite (includes Picture Vocabulary and Oral Reading Recognition tests).
Day 1(baseline for block 1), Day 14(post block 1), Day 70 (Baseline block 2), Day 84 (post block 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Ying-Hui Chou, Sc.D., University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

September 12, 2025

First Submitted That Met QC Criteria

September 24, 2025

First Posted (Estimated)

September 25, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25103278
  • 022713-00001 (Other Grant/Funding Number: Arizona Alzheimer's Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

N/A Will not be sharing data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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