Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02212405
Enrollment
8
Registered
2014-08-08
Start date
2014-07-31
Completion date
2015-12-31
Last updated
2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Deep rTMS, Insular cortex, PET, [11C]-PHNO

Brief 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.

Interventions

DEVICErepetitive Transcranial Magnetic Stimulation

Each participant will participate in all three arms to receive sham, 1hz and 10hz rTMS as well as PET imaging.

The 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.

Sponsors

Brainsway
CollaboratorINDUSTRY
Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy male or female * Between the ages of 19 and 45

Exclusion criteria

* Pregnancy. * Presence of metal objects in the body or implanted electronic devices, that preclude safe MR scanning. * Claustrophobia. * Cardiovascular or cerebrovascular diseases. * Major psychiatric disorders including mood, anxiety or psychotic disorders. * History of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor. * Gross structural brain abnormalities as revealed by T1 weighted images. * Current use or use during the previous month of medication that may affect the CNS (e.g. neuroleptics, bupropion). * Learning disability, amnesia or other conditions that impede memory and attention.

Design outcomes

Primary

MeasureTime frameDescription
Changes in [11C]-(+)-PHNO bindingParticipants will complete all sessions in a period of approximately 4 weeks.\[11C\]-(+)-PHNO binding at D2/3 receptors will be measured with PET imaging following rTMS at 1Hz, 10Hz, and sham stimulation. Binding at regions of interest will be compared between trial conditions.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026