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Not yet recruiting NCT07192913

Glymphatic Function TMS Study

Phase II Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07192913 · 25103278 · 022713-00001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗