Investigating the Physiology of Targeted Theta-burst Neuromodulation

November 25, 2015 updated by: Sarina Iwabuchi, Institute of Mental Health Nottingham
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2TU
        • Sarina Iwabuchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Device: theta-burst TMS
This protocol involves short periods of pulse delivery in combination with long periods of silent intervals.
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Mental Health Nottingham

Investigators

  • Principal Investigator: Sarina Iwabuchi, PhD, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 25, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • L14082014 SoM PAPsych

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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