Personalized Brain Stimulation to Help Veterans Quit Smoking

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT07050862
Status
Recruiting
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Conditions

  • Tabacco Use Disorder
  • rTMS

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation — DEVICE
    The first group will receive 10 Hz DTMS (standard TMS) with a protocol of 3 seconds on, 15 seconds off, and a total of 1800 pulses/session, lasting 18 minutes, targeting the bilateral insula and lateral prefrontal cortex.
  • Personalized-image-guided and E-field-modeling dose rTMS (precision TMS) — DEVICE
    With a protocol of 5 seconds on, 10 seconds off, and a total of 3000 pulses/session, lasting 15 minutes, targeting the left DLPFC.

Study Details

Cigarette smoking is a significant public health concern for Veterans. Encouraging smoking cessation continues to be a top priority for the Veterans' Administration as Veterans who use tobacco experience negative health effects, including cancer, heart disease, and mental disorders. Despite the efficacy of current evidence-based pharmacotherapies and psychotherapies for smoking cessation, alternative treatments are critically needed. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive form of brain stimulation, US FDA-approved for smoking cessation. In this protocol, the investigators propose comparing the two rTMS protocols (standard TMS vs. precision TMS) to find a better treatment parameter for smoking cessation in Veterans. Identifying an efficacious rTMS protocol would benefit Veterans who want to quit smoking.

Key Dates

First listed
Jul 3, 2025
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Deep rTMS
    The first group will receive 10 Hz DTMS (standard TMS) with a protocol of 3 seconds on, 15 seconds off, and a total of 1800 pulses/session, lasting 18 minutes, targeting the bilateral insula and lateral prefrontal cortex.
  • Experimental: Precision TMS
    The other group will receive 10 Hz personalized-image-guided and Efield-modeling dose rTMS (precision TMS) with a protocol of 5 seconds on, 10 seconds off, and a total of 3000 pulses/session, lasting 15 minutes, targeting the left dorsolateral prefrontal cortex (DLPFC).

Primary Outcome Measure

Cigarettes per day (CPD) [ Time Frame: The cigarettes per day will be measured up to 3 weeks for the outcome 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5703
R. Amanda C LaRue, PhD
[email protected]
(843) 789-6707
Sarah A Jackson, BA MA
[email protected]
(843) 789-6700
Xingbao Li, MD MS (PRINCIPAL_INVESTIGATOR)

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By research site
Ralph H. Johnson VA Medical Center, Charleston, SC· Charleston, SC

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