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CompletedNCT02616835Updated Nov 30, 2015

Investigating the Physiology of Targeted Theta-burst Neuromodulation

An interventional study of theta-burst TMS and sham theta-burst TMS in Healthy Volunteers, sponsored by Institute of Mental Health Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-30.

Sponsored by Institute of Mental Health Nottingham · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Institute of Mental Health Nottingham is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No personal history of neurological or psychiatric disorders

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Devicetheta-burst TMS

    This protocol involves short periods of pulse delivery in combination with long periods of silent intervals.

  • Devicesham 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)

06

What researchers measure

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

    Time frame: One hour

Secondary outcomes

  1. Changes in brain metabolites following TMS administration using MR spectroscopy

    Using MRI scans, changes in metabolites in the brain will be assessed following theta-burst TMS and sham TMS

    Time frame: One hour

07

Study locations

1 site
  • Sarina Iwabuchi
    Nottingham, Nottinghamshire NG7 2TU, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02616835
Lead sponsor
Institute of Mental Health Nottingham
Responsible party
Sarina Iwabuchi (Dr Sarina Iwabuchi, Institute of Mental Health Nottingham) — Principal investigator
First posted
Nov 30, 2015
Start date
Aug 2014
Primary completion
Mar 2015
Completion
Jun 2015
Last update
Nov 30, 2015

Study contacts

Sarina Iwabuchi, PhD
principal investigator · University of Nottingham
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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