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

July 18, 2019 updated by: Sujung Yoon, Ewha Womans University Mokdong Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rTMS + Wash-out period + Sham
  • 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
Repetitive transcranial magnetic stimulation
Sham Comparator: Sham + Wash-out period + rTMS
  • 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
Repetitive transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University Mokdong Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NRF_rTMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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