Investigating the Physiology of Targeted Theta-burst Neuromodulation

NCT ID: NCT02616835

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type EXPERIMENTAL

theta-burst TMS

Intervention Type DEVICE

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

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)

Group Type SHAM_COMPARATOR

sham theta-burst TMS

Intervention Type DEVICE

This protocol delivers theta-burst pulses from a sham device (i.e. at same speed and timeframe but without the magnetic output)

Interventions

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theta-burst TMS

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

Intervention Type 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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Mental Health Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Sarina Iwabuchi

Dr Sarina Iwabuchi

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarina Iwabuchi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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Sarina Iwabuchi

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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L14082014 SoM PAPsych

Identifier Type: -

Identifier Source: org_study_id