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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02616835
Other study ID # L14082014 SoM PAPsych
Secondary ID
Status Completed
Phase N/A
First received November 24, 2015
Last updated November 25, 2015
Start date August 2014
Est. completion date June 2015

Study information

Verified date November 2015
Source Institute of Mental Health Nottingham
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date June 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Device:
theta-burst TMS
This protocol involves short periods of pulse delivery in combination with long periods of silent intervals.
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)

Locations

Country Name City State
United Kingdom Sarina Iwabuchi Nottingham Nottinghamshire

Sponsors (1)

Lead Sponsor Collaborator
Institute of Mental Health Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 One hour No
Secondary 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 One hour No
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