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N/A Completed N=41 Randomized Double-blind Basic Science

Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking

Source: ClinicalTrials.gov NCT03960138 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Change in Behavioral Inhibition Between Baseline and 1 Hour Post Treatment. — -3.078; 3.778 Percentage of correct trials

Summary

The purpose of this research study is to examine the effects of theta-burst Transcranial Magnetic Stimulation on inhibitory control and smoking among adult cigarette smokers.

Outcome Measures

OutcomeResultp-value
PRIMARY
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Change in Behavioral Inhibition Between Baseline and 1 Hour Post Treatment.
-3.078; 3.778
PRIMARY
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 1 Hour Post Treatment.
37.281; 34.593
PRIMARY
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 24hrs Post Treatment Between Conditions.
28.656; 26.031
PRIMARY
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 48hrs Post Treatment Between Conditions.
29.781; 28.968
PRIMARY
The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Hyperdirect Brain Circuit Function Between Pre and Post Session.
-3.078; .321

Eligibility Criteria

Inclusion Criteria

  • Be between the ages of 18 and 65.
  • Be in stable mental and physical health.
  • Be willing to provide informed consent.
  • Be able to comply with protocol requirements and likely to complete all study procedures.
  • Be a current nicotine dependent cigarette smoker (smoke ≥10 cigs/day) with a minimum smoking history of smoking an average of ≥ 10 cigs/day over the past two years.

Exclusion Criteria

  • 1. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
  • Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for > 15 minutes, implanted electronic device, metal in the head, or pregnancy, as indicated by a positive urine pregnancy test at screening).
  • Any use of substances that lower seizure threshold (such as thyroid medications or cocaine).
  • History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
  • History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
  • Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.
  • BAC greater than 0.0. 8. Any other condition or concern that in the Investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03960138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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