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

NCT ID: NCT02932085

Last Updated: 2019-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-11-30

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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Neurostar TMS Therapy System, NeuroStar XPLOR System

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation

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

Group Type SHAM_COMPARATOR

Neurostar TMS Therapy System, NeuroStar XPLOR System

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation

Interventions

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Neurostar TMS Therapy System, NeuroStar XPLOR System

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sujung Yoon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Hong H, Kim RY, Song Y, Suh C, Lee H, Lyoo IK, Yoon S, Lim SM, Lee S. Genetic profile for dopamine signaling predicts brain functional reactivity to repetitive transcranial magnetic stimulation. Eur Arch Psychiatry Clin Neurosci. 2023 Feb;273(1):99-111. doi: 10.1007/s00406-022-01436-2. Epub 2022 Aug 11.

Reference Type DERIVED
PMID: 35951113 (View on PubMed)

Other Identifiers

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NRF_rTMS

Identifier Type: -

Identifier Source: org_study_id

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