Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device

Study Overview
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Brief Summary
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This study is a randomized, double-blind, and sham-controlled trial to examine the effects of transcranial magnetic stimulation on the brain of health individuals.

Detailed Description
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The efficacy of repetitive transcranial magnetic stimulation on the brain will be assessed by multimodal neuroimaging in healthy individuals.

Official Title
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Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device: A Single Institution, Randomized, Double-blind, Sham-controlled Study Using Multimodal Neuroimaging in Healthy Young Adults

Conditions
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Healthy

Intervention / Treatment
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* Device: Neurostar TMS Therapy System, NeuroStar XPLOR System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 19-39 years Informed consent Exclusion Criteria: Pregnancy or breastfeeding High fever patient Current and past history of seizure or epilepsy Evidence of epilepsy on EEG Pregnancy or possibility of pregnancy during period Major medical or neurological illnesses Evidence of alcohol intake on alcohol breath test Contraindications to MRI scans and transcranial magnetic stimulation Risk of skin burns Use of medications that could have influenced on the study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rTMS + Wash-out period + Sham<br>Five consecutive daily repetitive transcranial magnetic stimulation sessions (Neurostar TMS Therapy System, NeuroStar XPLOR System) Two weeks wash-out period Five consecutive daily sham stimulation sessions | Device: Neurostar TMS Therapy System, NeuroStar XPLOR System<br>* Repetitive transcranial magnetic stimulation<br>|
| Sham Comparator: Sham + Wash-out period + rTMS<br>Five consecutive daily sham stimulation sessions (Neurostar TMS Therapy System, NeuroStar XPLOR System) Two weeks wash-out period Five consecutive daily repetitive transcranial magnetic stimulation sessions | Device: Neurostar TMS Therapy System, NeuroStar XPLOR System<br>* Repetitive transcranial magnetic stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic brain changes in magnetic resonance imaging by computational approaches |  | after 5 sessions (1 session/day) equals 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional brain changes in magnetic resonance imaging by computational approaches |  | after 5 sessions (1 session/day) equals 5 days | 
| Standardized scores on a neuropsychological test battery |  | after 5 sessions (1 session/day) equals 5 days | 
| Analysis of EEG activity |  | after 5 sessions (1 session/day) equals 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial magnetic stimulation, Magnetic resonance imaging, Magnetic resonance spectroscopy