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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People Living with HIV/AIDS Who Smoke | Experimental | Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTBS | Device | 1800 pulses of iTBS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking | Cues Encompassing People Smoking Cigarettes. Measured after iTBS using visual probe task administered (adapted for smoking images) on a computer and eye tracker. Images of smoking and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds | baseline and immediately after intervention, approximately 4 hours |
| Change in Attentional Bias Sham Smoking | Cues Encompassing People Smoking Cigarettes. Measured after sham using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of smoking and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds | baseline and immediately after intervention, approximately 4 hours |
| Change in Attentional Bias iTBS Paraphernalia | Cues Encompassing Cigarette Paraphernalia. Measured after iTBS using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of cigarette paraphernalia and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds | baseline and immediately after intervention, approximately 4 hours |
| Change in Attentional Bias Sham Paraphernalia |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) iTBS | Craving measured using TCQ-SF. The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving. | baseline and immediately after intervention, approximately 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Resting State Functional Connectiivity | Measured in MRI scanner | Baseline |
| Resting State Functional Connectiivity | Measured in MRI scanner | Four hours from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gopalkumar Rakesh, MD | Assistant Professor, University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 245 Fountain Court | Lexington | Kentucky | 40509 | United States |
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A total of 9 participants were enrolled; however, 1 participant dropped out before the experimental sessions began.
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| ID | Title | Description |
|---|---|---|
| FG000 | People Living With HIV/AIDS Who Smoke | Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS (Intermittent Theta Burst Stimulation) and a sham comparator (TMS). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | People Living With HIV/AIDS Who Smoke | Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking | Cues Encompassing People Smoking Cigarettes. Measured after iTBS using visual probe task administered (adapted for smoking images) on a computer and eye tracker. Images of smoking and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds | Posted | Mean | Standard Error | milliseconds | baseline and immediately after intervention, approximately 4 hours |
|
4 weeks after intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | People Living With HIV/AIDS (PLWHA) Who Smoke | Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gopalkumar Rakesh | University of Kentucky | 859-562-2348 | gopalkumar.rakesh@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 7, 2023 | Apr 4, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Single blind within participant design
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All participants received iTBS (intermittent theta burst stimulation) first and sham subsequently but were blinded regarding treatment.
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| TMS | Device | MagVenture MagPro x100 device. This will be used as the comparator. |
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Cues Encompassing Cigarette Paraphernalia. Measured after sham using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of cigarette paraphernalia and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds |
| baseline and immediately after intervention, approximately 4 hours |
| Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) Sham |
Craving measured using TCQ-SF. The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving. |
| baseline and immediately after intervention, approximately 4 hours |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Change in Attentional Bias Sham Smoking | Cues Encompassing People Smoking Cigarettes. Measured after sham using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of smoking and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds | 3 participants who got itbs did not show up for the sham visit | Posted | Mean | Standard Error | milliseconds | baseline and immediately after intervention, approximately 4 hours |
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| Primary | Change in Attentional Bias iTBS Paraphernalia | Cues Encompassing Cigarette Paraphernalia. Measured after iTBS using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of cigarette paraphernalia and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds | Posted | Mean | Standard Error | milliseconds | baseline and immediately after intervention, approximately 4 hours |
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| Primary | Change in Attentional Bias Sham Paraphernalia | Cues Encompassing Cigarette Paraphernalia. Measured after sham using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of cigarette paraphernalia and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds | 3 participants who got itbs did not show up for the sham visit | Posted | Mean | Standard Error | milliseconds | baseline and immediately after intervention, approximately 4 hours |
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| Secondary | Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) iTBS | Craving measured using TCQ-SF. The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving. | Posted | Mean | Standard Error | score on a scale | baseline and immediately after intervention, approximately 4 hours |
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| Secondary | Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) Sham | Craving measured using TCQ-SF. The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving. | All participants completed the iTBS session but 3 participants did not show up for the sham visit | Posted | Mean | Standard Error | score on a scale | baseline and immediately after intervention, approximately 4 hours |
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| Other Pre-specified | Resting State Functional Connectiivity | Measured in MRI scanner | Not Posted | Baseline | Participants |
| Other Pre-specified | Resting State Functional Connectiivity | Measured in MRI scanner | Not Posted | Four hours from baseline | Participants |
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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