Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJuly 22, 2019
July 1, 2019
11 months
September 26, 2016
July 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic brain changes in magnetic resonance imaging by computational approaches
after 5 sessions (1 session/day) equals 5 days
Secondary Outcomes (3)
Functional brain changes in magnetic resonance imaging by computational approaches
after 5 sessions (1 session/day) equals 5 days
Standardized scores on a neuropsychological test battery
after 5 sessions (1 session/day) equals 5 days
Analysis of EEG activity
after 5 sessions (1 session/day) equals 5 days
Study Arms (2)
rTMS + Wash-out period + Sham
ACTIVE COMPARATOR* 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
SHAM COMPARATOR* 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
Interventions
Repetitive transcranial magnetic stimulation
Eligibility Criteria
You may qualify if:
- Aged 19-39 years
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 35951113DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 26, 2016
First Posted
October 13, 2016
Study Start
December 1, 2016
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
July 22, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share