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Neuromodulation

TMS-AD 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)
Awards & highlights

TMS-AD Trial 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.Check my eligibility
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.See study design
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.

TMS-AD Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EEG-based connectivity
Functional network connectivity
Vascular density (VAD)
+1 more
Secondary outcome measures
Brief Visuospatial Memory Test (BVMT-R)
Category & Phonemic Verbal Fluency
Hopkins Verbal Learning Test (HVLT-2)
+4 more

TMS-AD Trial Design

1Treatment groups
Experimental Treatment
Group I: TMS-ADExperimental Treatment1 Intervention
The study comprises one arm of four sessions. On Day 1 (~2 hr session), participants fill forms, complete a neuropsychological test battery (NIH Toolbox, NACC UDS, BDI), and provide a saliva sample to be banked for future APOE genotype determination. On Day 2 (~2 hr session), subjects will perform an initial MRI scanning session. In this session, MRI, RSFA, DWI, and fMRI are collected so they can be used for network-based targeting. On Days 3 participants will undergo a combined TMS-fMRI session (~2 hr session). On Day 4 participants wil undergo a combined TMS-EEG session(~2 hr session).
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
2,364 Previous Clinical Trials
3,420,492 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,735 Total Patients Enrolled
Simon W Davis, PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this research study still ongoing?

"As per the details available on clinicaltrials.gov, this investigation is presently in search of eligible participants. The trial was originally listed on April 1st, 2024, and most recently revised on March 8th, 2024."

Answered by AI

Is it possible for me to participate in this research trial?

"The clinical study seeks 150 individuals aged between 60 and 75 years with mild cognitive impairment. Essential requirements include fluency in English and willingness to provide informed consent."

Answered by AI

What is the total number of subjects actively involved in this research investigation?

"Indeed, information on clinicaltrials.gov verifies that this investigation is presently in need of volunteers. The trial was initially listed on April 1st, 2024 and its latest revision was made on March 8th, 2024. A total of 150 subjects are sought for from a single research site."

Answered by AI

Is there an age limit for participation in this medical research study, excluding individuals over 75 years old?

"Eligible participants for this study must fall within the age range of 60 to 75 years. Notably, there are separate trials available for individuals under 18 and those over 65 years old, with a total of 25 and 570 studies respectively."

Answered by AI

What are the primary objectives of this particular investigation?

"Additionally, secondary outcomes include evaluations using the Montreal Cognitive Assessment (MoCA), which serves as a rapid"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neuromodulation of Memory in Aging
2024. "Neuromodulation of Memory in Aging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05460468.
~100 spots leftby Jun 2027
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