Glymphatic Function TMS Study

NCT ID: NCT07192913

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active (TBS) - Sham (TBS)

Block 1: Active TBS Block 2: Sham TBS

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type 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.

Sham (TBS) - Active (TBS)

Block 1: Sham TBS Block 2: Active TBS

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Ying-hui Chou

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying-Hui Chou, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Central Contacts

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Reyna Hickey

Role: CONTACT

520-626-7755

Sarah Norman

Role: CONTACT

Other Identifiers

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022713-00001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

25103278

Identifier Type: -

Identifier Source: org_study_id