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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)
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 moreSecondary study objectives
Brief Visuospatial Memory Test (BVMT-R)
Category & Phonemic Verbal Fluency
Hopkins Verbal Learning Test (HVLT-2)
+4 moreTrial 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
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,710 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,804 Previous Clinical Trials
28,194,749 Total Patients Enrolled
Simon W Davis, PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
40 Total Patients Enrolled