Investigating the Physiology of Targeted Theta-burst Neuromodulation

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2015

Interventions

  • Device: theta-burst TMS
    • This protocol involves short periods of pulse delivery in combination with long periods of silent intervals.
  • Device: sham theta-burst TMS
    • This protocol delivers theta-burst pulses from a sham device (i.e. at same speed and timeframe but without the magnetic output)

Arms, Groups and Cohorts

  • Experimental: 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 Comparator: 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)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Institute of Mental Health Nottingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sarina Iwabuchi, Dr Sarina Iwabuchi – Institute of Mental Health Nottingham
  • Overall Official(s)
    • Sarina Iwabuchi, PhD, Principal Investigator, University of Nottingham

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