Bayesian Neurobehavioral Phenotyping: From Mechanism Identification to Personalized Neuromodulation Treatments. R61 PHASE

ConditionSmoking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorM.D. Anderson Cancer Center

About this trial

The goal of this clinical research study is to learn more about whether individual differences in brain responses to emotional triggers impact rTMS (repetitive transcranial magnetic stimulation) responses in people who smoke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 21 to 60 years

Report smoking on average, 5 or more cigarettes, little cigars and/or cigarillos per day, within the past 30 days preceding the screening visit.

Expired carbon monoxide (CO) ≥ 6ppm and/or test positive for cotinine using a urine cotinine test on day of study visit.

Able to follow verbal and written instructions in English and complete all aspects of the study.

Disqualifiers

rTMS exposure for treatment or research purposes in the last 6 months.

History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.

Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).

History of brain surgery, implanted electronic device, metal in the head.

Trial design

Design model

Single group

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

    Procedure/Surgery

    TMS is a non-invasive procedure in which a coil is placed over the scalp, and focused magnetic pulses are applied to parts of the brain through the coil.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: FP1 (cTBS) then F3 (iTBS)Experimental treatment 1 intervention
Group B: F3 (iTBS) then Fp1 (cTBS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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