Investigating the Physiology of Targeted Theta-burst Neuromodulation
1 other identifier
interventional
28
1 country
1
Brief Summary
This research seeks to study the physiological effects of theta-burst transcranial magnetic stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.
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-volunteers
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 24, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedNovember 30, 2015
November 1, 2015
7 months
November 24, 2015
November 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in functional connectivity following TMS administration using functional MRI
Changes in brain connectivity will be assessed by comparing functional MRI scans after theta-burst TMS and sham theta-burst TMS
One hour
Secondary Outcomes (1)
Changes in brain metabolites following TMS administration using MR spectroscopy
One hour
Study Arms (2)
theta-burst TMS
EXPERIMENTALTheta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)
sham theta-burst TMS
SHAM COMPARATORSham protocol for theta-burst transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)
Interventions
This protocol involves short periods of pulse delivery in combination with long periods of silent intervals.
This protocol delivers theta-burst pulses from a sham device (i.e. at same speed and timeframe but without the magnetic output)
Eligibility Criteria
You may qualify if:
- No personal history of neurological or psychiatric disorders
You may not qualify if:
- Have had a brain injury or neurological disorder
- Have ever suffered an epileptic fit
- Have any non-removable metal implants
- Drink more than 20 units of alcohol per week on a regular basis
- Currently take any illicit drugs on regular basis
- Likely to be pregnant
- Ever suffered from a serious mental illness such as schizophrenia, severe depression or bipolar disorder
- Currently take any psychotropic medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sarina Iwabuchi
Nottingham, Nottinghamshire, NG7 2TU, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Sarina Iwabuchi, PhD
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Sarina Iwabuchi
Study Record Dates
First Submitted
November 24, 2015
First Posted
November 30, 2015
Study Start
August 1, 2014
Primary Completion
March 1, 2015
Study Completion
June 1, 2015
Last Updated
November 30, 2015
Record last verified: 2015-11