Clinical Trials Directory

Trials / Completed

CompletedNCT02212405

Does the Insula Control Smoking-Induced Dopamine Release? A TMS/[11C]-PHNO Study in Humans.

Does the Insula Control Smoking-Induced Dopamine Release? A TMS/[11C]-PHNO Study in Humans (Part II).

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Centre for Addiction and Mental Health · Academic / Other
Sex
All
Age
19 Years – 45 Years
Healthy volunteers
Accepted

Summary

Findings from this study may demonstrate how the insula contributes to reward pathways involved in addiction. There are three main hypotheses for this trial. The first is that inhibiting the insula using transcranial magnetic stimulation (TMS) will not cause noticeable changes of dopamine release in the striatum. The second is that stimulating the insula with TMS will increase dopamine release in the striatum, and will be visualized on PET imaging as decreased radiotracer binding. The third hypothesis is that the participants will not experience major side effects from TMS on the insula.

Detailed description

This project will take advantage of the recently developed Deep rTMS coil to target the insular cortex. Few studies have examined the possibility of using repetitive Transcranial Magnetic Stimulation (rTMS) for nicotine addiction and none so far have explored the use of a coil that specifically targets the insular region. The objective of this study is to test whether low and high-frequency rTMS of the insula modulates striatal dopamine (DA) release in healthy humans. Positron Emission Tomography (PET) with \[11C\]-(+)-PHNO, a radiotracer which is very sensitive to fluctuations in DA transmission in the human brain, will be used to assess the impact of rTMS on dopamine levels. This project will yield the first data in humans linking the insula to the DA system in vivo. These findings could lead to the identification of optimal parameters for Deep rTMS to use secondarily in a proof of principle clinical study in smokers.

Conditions

Interventions

TypeNameDescription
DEVICErepetitive Transcranial Magnetic StimulationEach participant will participate in all three arms to receive sham, 1hz and 10hz rTMS as well as PET imaging.
OTHERrepetitive Transcranial Magnetic Stimulation ShamThe sham coil is built in the same helmet of the active coil. The sham coil is has a circular shape and placed perpendicular to the scalp within the same helmet. This coil produces a similar sound and scalp sensation as the real coil.

Timeline

Start date
2014-07-01
Primary completion
2015-12-01
Completion
2015-12-01
First posted
2014-08-08
Last updated
2016-09-01

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02212405. Inclusion in this directory is not an endorsement.