Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Device: Repetitive transcranial magnetic stimulation, MagStim Rapid2; Device: Sham repetitive transcranial magnetic stimulation

• Registration Number: NCT02590640
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study plans to learn more about the way an experimental technique called "transcranial magnetic stimulation" (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain.

For interested participants, this study requires a single 3 hour appointment, which will include MRI of the brain as well as TMS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Study Start: 2015-11
• Primary Completion: 2019-09-06
• Study Completion: 2019-09-06
• Status Verified: 2022-06
• Results First Submitted: 2022-06-21
• Results First Submitted QC: 2022-06-21
• Last Update Submitted: 2022-06-21
• Results First Posted: 2022-07-13
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18-55
2. Ability to provide informed consent
3. Self-reported current average daily cigarette consumption >10/day for at least 1 year
4. Self-reported motivation to quit smoking

Exclusion Criteria

1. MRI/TMS exclusions, including

   • Claustrophobia
   • Intracranial or spinal hardware
   • Pacemakers
   • MR-incompatible devices (Examples: pacemaker, deep brain stimulator, vagal nerve stimulator, cochlear implant, insulin pump, implanted medication pump, bone stimulator, implanted defibrillator)
   • History of metal objects or fragments in the eye or skull, including shrapnel or metal plates
   • History of stroke or other brain lesion
   • History of attempted suicide or suicidal ideation
   • Personal history of headaches, seizures, epilepsy, or status epilepticus
   • Family history of epilepsy
   • Medications known to lower seizure threshold (e.g., tricyclic antidepressants, antipsychotics, psychostimulants)
   • Increased intracranial pressure, hydrocephalus, or pseudotumor cerebri
   • Unstable coronary artery disease
   • Current pregnancy or positive urine pregnancy test

2. Neurological illness

3. Prior neurosurgery

4. Schizophrenia

5. Bipolar disorder

6. Current (within the last two months) major depressive disorder

7. Substance dependence or positive urinalysis for opiates, stimulants, cannabis, or sedative on the day of testing

8. Alcohol dependence or positive breath test for alcohol on the day of testing

9. Use of tobacco products other than cigarettes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhibitory insular rTMS	Repetitive transcranial magnetic stimulation, MagStim Rapid2	Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers.
Sham insular rTMS	Sham repetitive transcranial magnetic stimulation	Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.

Primary Outcome Measures

Name	Time	Method
Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping	1 hour
Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ	1 hour	Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ)
Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping	1 hour

Trial Locations

Locations (1)

University of Colorado Department of Radiology; 🇺🇸 Aurora, Colorado, United States