Investigating the Physiology of Targeted Theta-burst Neuromodulation

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: theta-burst TMS; Device: sham theta-burst TMS

• Registration Number: NCT02616835
• Lead Sponsor: Institute of Mental Health Nottingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-03
• Study Completion: 2015-06
• Status Verified: 2015-11
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-25
• Last Update Submitted: 2015-11-25
• Study First Posted: 2015-11-30
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• No personal history of neurological or psychiatric disorders

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
theta-burst TMS	theta-burst TMS	Theta-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 theta-burst TMS	Sham protocol for theta-burst transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)

Primary Outcome Measures

Name	Time	Method
Changes in functional connectivity following TMS administration using functional MRI	One hour	Changes in brain connectivity will be assessed by comparing functional MRI scans after theta-burst TMS and sham theta-burst TMS

Secondary Outcome Measures

Name	Time	Method
Changes in brain metabolites following TMS administration using MR spectroscopy	One hour	Using MRI scans, changes in metabolites in the brain will be assessed following theta-burst TMS and sham TMS

Trial Locations

Locations (1)

Sarina Iwabuchi; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom