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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Neurostar TMS Therapy System, NeuroStar XPLOR System

• Registration Number: NCT02932085
• Lead Sponsor: Ewha Womans University Mokdong Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Study Start: 2016-12
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Aged 19-39 years
• Informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
rTMS + Wash-out period + Sham	Neurostar TMS Therapy System, NeuroStar XPLOR System	* 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
Sham + Wash-out period + rTMS	Neurostar TMS Therapy System, NeuroStar XPLOR System	* 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

Primary Outcome Measures

Name	Time	Method
Metabolic brain changes in magnetic resonance imaging by computational approaches	after 5 sessions (1 session/day) equals 5 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of