NeuroControl of Nicotine Dependence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive Transcranial Magnetic Stimulation (rTMS).
- Who it may be relevant to
- Registry conditions: Nicotine Dependence. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neuronavigated Non-invasive Brain Stimulation for Nicotine Dependence.
Overview
The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours.
Interventions
- Device Repetitive Transcranial Magnetic Stimulation (rTMS)
Continuous theta burst rTMS
Primary outcome measures
- Acute effects of cTBS on cognitive control [Time frame: 1 hour after receiving cTBS]
Secondary outcome measures (1)
- Exploratory: Acute effects of cTBS on fMRI brain response [Time frame: 1 hour after receiving cTBS]
Eligibility criteria
Inclusion criteria
- Nicotine Dependence as measured by: Smoke ≥ 8 cigarettes/day for ≥ 2 yrs, expired carbon monoxide (CO) concentration of ≥ 10 ppm, positive urine cotinine test and FTND score ≥ 3 Or ≥ 15 uses of electronic cigarette/day for ≥ 1 year, positive urine cotinine test, and PS-ECDI score ≥ 3
- English Fluency
- Functional Vision (with corrective lenses as needed)
Exclusion criteria
- Use of psychotropic and antiepileptic medications in the last month
- Presence of an untreated illness or serious medical condition
- History of major neurological illness
- Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for >15 min., implanted electronic device, metal in the head) or MRI.
- Any use of substances that lower seizure threshold.
- Current or past psychosis
- Electroconvulsive therapy in the past 6 months
- Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
- BAC greater than 0.0.
- Positive urine pregnancy test
- Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Health Neuroscience Center — Columbia
Identifiers
NCT: NCT06347055 · 403690