Neuromodulation of Memory in Aging

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05460468
Status
Recruiting
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Conditions

  • MCI
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Transcranial Magnetic Stimulation — DEVICE
    Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve a variety of cognitive conditions, and to probe the dynamics of normal brain function.

Study Details

The proposed research will use closed-loop transcranial magnetic stimulation (TMS) based on individualized brain networks to establish parameters that can reliably control brain states. This will be tested in healthy aging and mild cognitive impairment (MCI) cohorts. The investigators will study network activation and neural oscillatory mechanisms underlying the network that regulates working memory and then target this network using closed-loop TMS to the Prefrontal Cortex. Investigators will measure the impact of TMS on working memory performance and task-based neural activity. The project will use brain stimulation and network modeling techniques to enhance working memory in healthy older adults and MCI and will demonstrate the value of closed-loop, network-guided TMS for future clinical applications.

Key Dates

Start date
Mar 28, 2024
Status verified
Oct 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: TMS-Randomized
    Three different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In the first condition, arrhythmic TMS trains with a stochastic (randomized) inter-pulse interval, will be used to disrupt cortical alpha oscillations and thus be expected to enhance memory performance.
  • Experimental: TMS-Ordered
    Three different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In the second condition, rhythmic (ordered) alpha-frequency TMS trains, with the expectation that this alpha stimulation will further entrain a synchronization during the task and thereby worsen memory performance.
  • Sham Comparator: TMS-Sham
    Three different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In a third condition, sham stimulation will be delivered at the same randomized inter-pulse interval, but with no TMS delivered to the brain.

Primary Outcome Measure

Working Memory Task [ Time Frame: Collected during TMS-EEG (Day 4) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University HospitalDurhamNorth Carolina27710
Simon Davis, PhD
[email protected]
919-668-0437
Emily Finch, BS
[email protected]
9196682299

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By research site
Duke University Hospital· Durham, NC

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