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

Sponsor
Ewha Womans University Mokdong Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02932085
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
11
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Neurostar TMS Therapy System, NeuroStar XPLOR System
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Metabolic brain changes in magnetic resonance imaging by computational approaches [after 5 sessions (1 session/day) equals 5 days]

Secondary Outcome Measures

  1. Functional brain changes in magnetic resonance imaging by computational approaches [after 5 sessions (1 session/day) equals 5 days]

  2. Standardized scores on a neuropsychological test battery [after 5 sessions (1 session/day) equals 5 days]

  3. Analysis of EEG activity [after 5 sessions (1 session/day) equals 5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ewha Womans University Mokdong Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Ewha Womans University Mokdong Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sujung Yoon, Professor, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier:
NCT02932085
Other Study ID Numbers:
  • NRF_rTMS
First Posted:
Oct 13, 2016
Last Update Posted:
Jul 22, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Sujung Yoon, Professor, Ewha Womans University Mokdong Hospital
Transcranial magnetic stimulation
Magnetic resonance imaging
Magnetic resonance spectroscopy

Study Results

No Results Posted as of Jul 22, 2019