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NCT Number: NCT07192913

Glymphatic Function TMS Study

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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.

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Reyna Hickey

CONTACT

[email protected]

520-626-7755

Sarah Norman

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Acronym: GF-TMS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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