TMS for Smoking Cessation in PLWHA Cessation in People Living With HIV/AIDS (PLWHA)
Condition: Smoking Cessation; HIV; Craving
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The pilot study proposal aims to modulate craving and attentional bias towards smoking cues
      in 40 people living with HIV/AIDS (PLWHA) using transcranial magnetic stimulation (TMS), with
      functional MRI (fMRI) brain correlates. TMS is a form of noninvasive brain stimulation and
      modulates neural activity using tiny doses of focused electricity. For the study,
      participants would perform two cognitive tasks and neuroimaging before and after the TMS and
      investigators would compare changes in these paradigms with TMS. The investigators will also
      get a point of contact urine drug screen before study initiation. The investigators will aim
      to recruit 20 subjects in each arm of our trial (total of 40) from the BlueGrass HIV Clinic.
    

Detailed description: 
      People living with HIV/AIDS (PLWHA) smoke at nearly three times the rate of the general
      population. These extraordinary smoking rates are associated with greater AIDS-related
      cancer, non-AIDS related morbidity including non-AIDS-defining cancer, cardiovascular
      disease, pulmonary disease, and mortality. Smoking significantly impacts the progression and
      outcome of HIV disease and has been identified as the leading contributor to premature
      mortality in PLWHA. Suboptimal results with current smoking cessation strategies makes
      identifying new adjunct strategies an area of need. The pilot study proposal aims to modulate
      craving and attentional bias towards smoking cues in people living with HIV/AIDS (PLWHA)
      using transcranial magnetic stimulation (TMS), with functional MRI (fMRI) brain correlates.
      TMS is a form of noninvasive brain stimulation and modulates neural activity using tiny doses
      of focused electricity. The TMS paradigm we would be performing is called theta burst
      stimulation (TBS), which is potent, short, and efficient. It has shown to cause
      neuroplasticity even with a single session and was approved by the FDA for treatment of major
      depressive disorder in 2019.

      Targeting the left dorsolateral prefrontal cortex (DLPFC) by using MNI coordinates
      (-44,40,29) via Brainsight Neuronavigation will modulate craving and attentional bias that is
      closely associated with craving. For this pilot study, 40 participants will perform the
      attentional bias task, craving scale and neuroimaging before and after the TBS/ sham TMS
      session, to compare changes in these paradigms between these interventions. Attentional bias
      would be measured with eye tracking, craving will be assessed with tobacco craving
      questionnaire (TCQ-SF). The investigators will aim to recruit 10 subjects from the BlueGrass
      HIV Clinic, who have an established pipeline for enrolling PLWHA patients in clinical trials.
      Although there is limited data on TMS in smoking, there have been no TMS studies done in
      PLWHA
    

Intervention name(s): iTBS; TMS
Intervention type(s): Device; Device
Intervention description(s): 1800 pulses of iTBS; MagVenture MagPro x100 device. This will be used as the comparator.
Other intervention name(s): Intermittent theta burst stimulation; Transcranial magnetic stimulation
Intervention model: Single Group Assignment
Intervention model description: Single blind within participant design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transcranial magnetic stimulation (TMS); Attentional bias; Conditioning