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Neuromodulation

Transcranial Magnetic Stimulation for Mild Cognitive Impairment (TMS-AD Trial)

N/A

Recruiting

Led By Simon W Davis, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected during tms-eeg (day 4)

Summary

This trial aims to use a technique called transcranial magnetic stimulation (TMS) to improve brain function in both healthy older adults and those with mild cognitive impairment. The researchers will target specific brain networks

Who is the study for?

This trial is for English-speaking adults who are experiencing mild cognitive impairment or general cognitive decline. Participants must be willing to provide consent. It aims to help those noticing memory challenges associated with aging.

What is being tested?

The study tests a technique called closed-loop transcranial magnetic stimulation (TMS), targeting the Prefrontal Cortex, to improve working memory in older adults and those with mild cognitive impairment by modulating brain networks.

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. Most people tolerate it well without serious side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected during tms-eeg (day 4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected during tms-eeg (day 4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected during tms-eeg (day 4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EEG-based connectivity

Functional network connectivity

Vascular density (VAD)

+1 more

Secondary study objectives

Brief Visuospatial Memory Test (BVMT-R)

Category & Phonemic Verbal Fluency

Hopkins Verbal Learning Test (HVLT-2)

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: TMS-RandomizedExperimental Treatment1 Intervention

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.

Group II: TMS-OrderedExperimental Treatment1 Intervention

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.

Group III: TMS-ShamPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

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