Does the Insula Control Smoking-Induced Dopamine Release? A TMS/[11C]-PHNO Study in Humans.
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jul 2014
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 30, 2014
CompletedFirst Posted
Study publicly available on registry
August 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 1, 2016
August 1, 2016
1.4 years
July 30, 2014
August 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in [11C]-(+)-PHNO binding
\[11C\]-(+)-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.
Participants will complete all sessions in a period of approximately 4 weeks.
Study Arms (3)
rTMS Sham + PET
SHAM COMPARATORAn advanced sham coil will be used that mimicks the sound and sensation of real repetitive Transcranial Magnetic Stimulation. The repetitive Transcranial Magnetic Stimulation sham intervention is followed by radiotracer and PET.
rTMS 1Hz + PET
EXPERIMENTALDeep repetitive Transcranial Magnetic Stimulation will be applied to the insula for 30 minutes. This will consist of 20 trains each comprising of 50 pulses at 1Hz. The inter-train interval is 15 seconds. The intervention is followed by radiotracer and PET.
rTMS 10Hz + PET.
EXPERIMENTALDeep repetitive Transcranial Magnetic Stimulation will be applied to the insula for 30 minutes. This will consist of 34 trains each comprising of 30 pulses at 10Hz. The inter-train interval is 3 seconds. The intervention is followed by radiotracer and PET.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy male or female
- Between the ages of 19 and 45
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre for Addiction and Mental Healthlead
- Brainswaycollaborator
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
Related Publications (1)
Malik S, Jacobs M, Cho SS, Boileau I, Blumberger D, Heilig M, Wilson A, Daskalakis ZJ, Strafella AP, Zangen A, Le Foll B. Deep TMS of the insula using the H-coil modulates dopamine release: a crossover [11C] PHNO-PET pilot trial in healthy humans. Brain Imaging Behav. 2018 Oct;12(5):1306-1317. doi: 10.1007/s11682-017-9800-1.
PMID: 29170944DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard LeFoll, M.D., Ph.D
CAMH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, MD, PhD, CCFP
Study Record Dates
First Submitted
July 30, 2014
First Posted
August 8, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
September 1, 2016
Record last verified: 2016-08