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Neuromodulation

TMS for Mild Cognitive Impairment (NetTMS 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
Elderly: age between 55-80
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 3 followup sessions (day 2, day 3, day 4)
Awards & highlights

NetTMS Trial Summary

This trial will test a new way to use MRI-derived measures of brain connectivity to guide transcranial magnetic stimulation (TMS) to improve memory function in adults with mild cognitive impairment (MCI).

Who is the study for?
This trial is for English-speaking adults aged 55-80 with mild cognitive impairment (MCI) who can consent to the study and are willing to use birth control if applicable. It's not for those with a history of substance abuse, pregnant or breastfeeding women, people with certain mental disorders, intracranial implants, pacemakers, seizure risks, significant head trauma or neurological conditions like dementia.Check my eligibility
What is being tested?
The trial tests a new approach using transcranial magnetic stimulation (TMS), guided by MRI brain connectivity measures. The goal is to see if TMS can improve memory in older adults with MCI compared to fake (sham) treatment.See study design
What are the potential side effects?
Potential side effects of TMS may include discomfort at the stimulation site, headache, lightheadedness, risk of seizure in susceptible individuals and other less common symptoms such as hearing loss if ear protection isn't used.

NetTMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 55 and 80 years old.

NetTMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 3 followup sessions (day 2, day 3, day 4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during 3 followup sessions (day 2, day 3, 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
Change in Episodic Memory Task Performance (accuracy and response time)
Change in neurovascular reactivity, as measured by resting-state fluctuations in activity (RSFA)
Change in structural connectivity, as measured by fractional anisotropy (FA)

NetTMS Trial Design

1Treatment groups
Experimental Treatment
Group I: Network-guided TMSExperimental Treatment1 Intervention
The study comprises one arm of five sessions. In Day 1 (~1.5 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 (~1 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. In Days 3-5 (each comprising a ~2.5 hr session) a few days later participants will undergo combined TMS-fMRI sessions. In the scanner, participants complete four fMRI runs: 2 runs using either a network-based or standard target location, counterbalanced across participants. Active and Sham TMS trials are intermixed within each run.
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
2,363 Previous Clinical Trials
3,420,446 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,559 Total Patients Enrolled
Simon W Davis, PhDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Network-guided TMS in Early Alzheimer's Disease
2022. "Network-guided TMS in Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04549155.
All > Alzheimers Disease High Point
~4 spots leftby Aug 2024
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