HIV Clinical Trial
Official title:
Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
NCT number | NCT04936594 |
Other study ID # | 64473 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 24, 2021 |
Est. completion date | November 24, 2021 |
Verified date | June 2023 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | November 24, 2021 |
Est. primary completion date | November 24, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients enrolled in the Bluegrass Clinic - Confirmed chart diagnosis of a HIV and receiving HIV treatment at the participating HIV clinic - Age 18-60 years - Preferably right hand dominant - Currently self-report smoking 10 of more cigarettes per day or a score of > 5 on the Fagerstrom Test for Nicotine - Willing and able to abstain from all drug use - Exhaled breath on day of study Carbon Monoxide < 10 ppm - Stabilized on maintenance buprenorphine if having comorbid opioid use disorder - Able to read and speak English - Able to provide informed consent to participate. Exclusion Criteria: - Pregnant, nursing, or becoming pregnant during the study - History of traumatic brain injury or seizures which are contraindications for transcranial magnetic stimulation (TMS) - Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, increased intracranial pressure, or history of significant head trauma with loss of consciousness for = 5 minutes which are all contraindications for TMS - Presence of intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes), cardiac pacemakers, or vagus nerve stimulation device which are all contraindications for magnetic resonance imaging - Neurological disorder including, but not limited to: space occupying brain lesion; any history of seizures, history of cerebrovascular accident; fainting, cerebral aneurysm, major neurocognitive disorder, Huntington chorea; multiple sclerosis which are all contraindications for TMS. |
Country | Name | City | State |
---|---|---|---|
United States | 245 Fountain Court | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Gopalkumar Rakesh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Resting State Functional Connectiivity | Measured in MRI scanner | Baseline | |
Other | Resting State Functional Connectiivity | Measured in MRI scanner | Four hours from baseline | |
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 | baseline and immediately after intervention, approximately 4 hours | |
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 | baseline and immediately after intervention, approximately 4 hours | |
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 | baseline and immediately after intervention, approximately 4 hours | |
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 | baseline and immediately after intervention, approximately 4 hours | |
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. | baseline and immediately after intervention, approximately 4 hours | |
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. | baseline and immediately after intervention, approximately 4 hours |
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