Non-Invasive Deep Brain Neuromodulation for Smoking Cessation

This study is testing a new way to help people quit smoking using a device called low intensity focused ultrasound (LIFU). LIFU aims to target specific areas deep in the brain linked to nicotine addiction. You would receive either active LIFU treatments or sham (inactive) LIFU treatments, two times a week for four weeks. Researchers will measure how many cigarettes you smoke per day and look at your brain activity using fMRI (functional magnetic resonance imaging) scans to see if the treatment is successful. To join, you need to be between 20 and 60 years old, have smoked for at least five years, and meet other health requirements. The study plans to enroll 100 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 100 participants, but the phase of the study is not specified.
What's involved
You would receive two LIFU sessions a week for four weeks. You will also have assessments at baseline, after session 1, after session 8, and at a one-week follow-up, which includes fMRI scans.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a one-week follow-up appointment about five weeks after starting the study.

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NCT07298902

Non-Invasive Deep Brain Neuromodulation for Smoking Cessation

Recruiting
NAAges 20–60InterventionalTreatment
The University of Texas Health Science Center, Houston
~100 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Low intensity focused ultrasound with active stimulationslow intensity focused ultrasound with sham stimulations

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cigarette per day (CPD)
Measured over Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).
+1 more outcome measured
Nicotine Addiction
1 sites across 1 states
Texas1
  • Xiaoming Du, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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  • Cigarette per day (CPD)Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline).

    Cigarette per day (CPD) is measured to index smoking reduction and cessation.

  • Brain connectivity as indicated by resting state functional connectivity (rsFC) value as assessed by functional magnetic resonance imaging (fMRI)session 1 (about 1-2 days after baseline) and session 8 (about 4 weeks after baseline).

    The strength of rsFC from fMRI is used to represent the brain activities that are corresponding to the transcranial magnetic stimulation (TMS) effect on smoking reduction/cessation.