Glymphatic Function TMS Study

NCT07192913 | Not Yet Recruiting Phase 2 FDA Device

• 2 other identifiers: 25103278022713-00001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• NIH Toolbox

  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)

Study Arms (2)

Active (TBS) - Sham (TBS)

EXPERIMENTAL

Block 1: Active TBS Block 2: Sham TBS

Device: Transcranial Magnetic Stimulation

Sham (TBS) - Active (TBS)

EXPERIMENTAL

Block 1: Sham TBS Block 2: Active TBS

Device: Transcranial Magnetic Stimulation

Interventions

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.

Active (TBS) - Sham (TBS); Sham (TBS) - Active (TBS)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with mild cognitive impairment (MCI Group)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Ying-Hui Chou, Sc.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reyna Hickey

CONTACT

520-626-7755; reynah@arizona.edu

Sarah Norman

CONTACT

snorman@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 25, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share