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

Ewha Womans University

Status: Completed

Conditions: Healthy

Treatments: Device: Neurostar TMS Therapy System, NeuroStar XPLOR System

Study type: Interventional

Funder types: Other

Identifiers

NCT02932085

NRF_rTMS

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 19 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

rTMS + Wash-out period + Sham

Active Comparator group

Description:

* 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

Treatment:

Device: Neurostar TMS Therapy System, NeuroStar XPLOR System

Sham + Wash-out period + rTMS

Sham Comparator group

Description:

* 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

Treatment:

Device: Neurostar TMS Therapy System, NeuroStar XPLOR System