Glymphatic Function TMS Study (GF-TMS)

University of Arizona

Status and phase: Not yet enrolling; Phase 2

Conditions: Mild Cognitive Impairment

Treatments: Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07192913

022713-00001 (Other Grant/Funding Number)

25103278

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Active (TBS) - Sham (TBS)

Experimental group

Description:

Block 1: Active TBS Block 2: Sham TBS

Treatment:

Device: Transcranial Magnetic Stimulation

Sham (TBS) - Active (TBS)

Experimental group

Description:

Block 1: Sham TBS Block 2: Active TBS

Treatment:

Device: Transcranial Magnetic Stimulation