Mild Cognitive ImpairmentPhase 2GF-TMSNCT07192913
Glymphatic Function TMS Study
A Phase 2 study testing Transcranial Magnetic Stimulation in people with Mild Cognitive Impairment, run by University of Arizona.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sarah Norman contact
About this study
Official title: 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active (TBS) - Sham (TBS) | Experimental | Block 1: Active TBS Block 2: Sham TBS Receives: Device: Transcranial Magnetic Stimulation |
| Sham (TBS) - Active (TBS) | Experimental | Block 1: Sham TBS Block 2: Active TBS Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1(baseline for block 1), Day 14(post block 1), Day 70 (Baseline block 2), Day 84 (post block 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying-hui Chou, University of Arizona
- Investigators
- Ying-Hui Chou, Sc.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192913
- Sponsor's protocol ID
- 25103278
- Other IDs
- 022713-00001
- Acronym
- GF-TMS
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: N/A Will not be sharing data
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Transcranial Magnetic Stimulation (TMS) on Amyloid and Tau Clearance Via Glymphatic Function in Prodromal Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07192913
- Acronym / sponsor ID
- GF-TMS / 25103278
- Conditions
- Mild Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active (TBS) - Sham (TBS) | Experimental | Device: Transcranial Magnetic StimulationBlock 1: Active TBS Block 2: Sham TBS |
| Sham (TBS) - Active (TBS) | Experimental | Device: Transcranial Magnetic StimulationBlock 1: Sham TBS Block 2: Active TBS |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationTMS 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. | Device | Active (TBS) - Sham (TBS), Sham (TBS) - Active (TBS) |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No. N/A Will not be sharing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Norman contact
Ying-Hui Chou, Sc.D. principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial Magnetic Stimulation in people with Mild Cognitive Impairment, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reyna Hickey (520-626-7755, reynah@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.