Recruiting

Neuromodulation

Sponsor:

Indiana University

Code:

NCT05460468

Conditions

Mild Cognitive Impairment

MCI

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

Brief summary:

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.

Conditions

Mild Cognitive Impairment

MCI

Study ID

NCT05460468

Start date

Mar 28, 2024

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • English Speaking
  • Willing to provide consent

Exclusion Criteria:

  • History of any Axis I DSM-V disorder, excluding major depressive disorder or generalized anxiety disorders
  • Current history of substance abuse or dependence (excluding nicotine)
  • Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes), cardiac pacemakers, or vagus Nerve stimulation device
  • Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, increased intracranial pressure, or history of significant head trauma with loss of consciousness for ≥ 5 minutes.
  • Neurological disorder including, but not limited to: space occupying brain lesion; any history of seizures, history of cerebrovascular accident; fainting, cerebral aneurysm, Dementia, Hungtington chorea; Multiple Sclerosis.
  • Current use of medications known to lower the seizure threshold and/or affect working memory

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Transcranial Magnetic Stimulation

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.

Primary outcome measure

  • Working Memory Task [ Time Frame: Collected during TMS-EEG (Day 4) ]
  • Functional network connectivity [ Time Frame: Collected during the initial neuroimaging session (Day 2) ]
  • Vascular density (VAD) [ Time Frame: Collected during the second neuroimaging session (Day 3) ]
  • EEG-based connectivity [ Time Frame: Collected during TMS-EEG (Day 4) ]

Central Contacts and Locations

Central contacts

Simon W Davis, PhD

9196841243simon.davis@duke.edu

Emily Finch, BA

9196682842emily.finch@duke.edu

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Simon Davis, PhD

9196680437simon.davis@duke.edu

Emily Finch, BS

9196682299emily.finch@duke.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • TMS
  • Transcranial Magnetic Stimulation
  • Memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-11.