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TMS Network Activity Modeling for Healthy Subjects
N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal hearing and (corrected) vision
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded in each bi-focal tms (pas) session, on average on days 28, 35, and 42 (sessions 3, 4, and 5, respectively).
Awards & highlights
Study Summary
This trial is studying the physiology of connectivity between brain regions in healthy human volunteers.
Who is the study for?
This trial is for healthy individuals with normal hearing and vision (corrected if necessary) who can understand and consent to participate. It's not suitable for those with metal in their body, heart devices, neurological or psychiatric conditions affecting brain function, developmental disorders, seizure history, substance abuse issues, pregnancy or breastfeeding.Check my eligibility
What is being tested?
The study tests how the brain's network activity responds to non-invasive stimulation using transcranial magnetic stimulation (TMS). It measures connectivity between brain regions by delivering single-pulse TMS while recording EEG data. The effects of varying time intervals between pulses on different areas are also explored.See study design
What are the potential side effects?
As all techniques used in this study are non-invasive and considered safe for healthy participants without contraindications listed above, significant side effects are not expected. However minor discomfort from the TMS procedure may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hearing and vision, with aids if necessary, are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recorded in each bi-focal tms (pas) session, on average on days 28, 35, and 42 (sessions 3, 4, and 5, respectively).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded in each bi-focal tms (pas) session, on average on days 28, 35, and 42 (sessions 3, 4, and 5, respectively).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cortico-cortical evoked potential (ccEP) amplitudes
Cortico-cortical evoked potential (ccEP) latencies
Secondary outcome measures
Change in bimanual coordination task (BCT) performance
Change in resting-state EEG (rs-EEG) connectivity using phase slope index (PSI)
MRI functional connectivity
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Healthy participantsExperimental Treatment2 Interventions
All participants participate in five core sessions. Session 1 consists of MRI scans (T1-weighted, T2-weighted, diffusion MRI, resting-state fMRI). Thereafter, there are four TMS-EEG sessions. Session 2 delivers uni-focal spTMS to various cortical targets while EEG is recorded to determine inter-regional conduction delays. Thereafter, Sessions 3 - 5 deliver bi-focal TMS (PAS), each session using a different asynchrony (shorter, equal to, or longer than the conduction delay). The three PAS sessions are at least one week apart. Each of the PAS sessions have three segments: (a) TMS-EEG-behavioral recordings before PAS, (b) the PAS modulation, and (c) TMS-EEG-behavioral recordings after PAS.
In addition to these core sessions, some participants may be invited for additional sessions for parameter optimization and for assessing test-retest repeatability.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,275 Total Patients Enrolled
Aapo Nummenmaa, PhDStudy DirectorMass General Brigham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My hearing and vision, with aids if necessary, are normal.I understand the study and can give my consent.I have a brain-related condition or take medication that affects my brain function.I have a history of epilepsy or seizures.I have surgical clips in my head or have had brain surgery before.I have been diagnosed with Meniere's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment criteria for this experiment restricted to those 40 and under?
"Per the study's enrollment rules, individuals must be 18 years of age or older and younger than 65 in order to participate."
Answered by AI
What is the major aim of this research endeavor?
"The primary assessment of this trial, taken every two weeks (on days 28, 35 and 42) is cortical-cortical evoked potential latencies. Secondary objectives include gauging shifts in resting state EEG connectivity using the Phase Slope Index as well as changes to bimanual coordination task performance following PAS modulation. Additionally, MRI functional connections between stimulated areas are also being monitored for alterations."
Answered by AI
Are individuals currently being accepted for participation in this exploration?
"According to clinicaltrials.gov, this health study is no longer recruiting patients; the last update was on March 11th 2022. Although patient recruitment has concluded for this trial, there are currently 839 other trials actively enrolling participants."
Answered by AI
To whom is this medical trial available?
"80 healthy individuals (aged 18-64) are eligible to enrol in this trial, providing they satisfy all necessary conditions including normal hearing/vision and the capacity for informed consent."
Answered by AI
Who else is applying?
What state do they live in?
New York
Massachusetts
New Hampshire
How old are they?
18 - 65
What site did they apply to?
Mass General Brigham
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
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