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| ID | Type | Description | Link |
|---|---|---|---|
| 2P30CA177558-11 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The study will examine the effects of two continuous theta burst stimulation (cTBS) sessions (given in a single day) on resting state functional MRI (fMRI), alcohol cue related attentional bias and alcohol craving in patients with alcohol use disorder (AUD).
Although pharmacotherapy and behavioral treatments have been approved for AUD, their effects sizes are modest. Noninvasive neuromodulation like Transcranial magnetic stimulation (TMS) can offer an alternative treatment option for AUD. TMS is a method of noninvasive neuromodulation that utilizes a magnetic field to focal electrical current in the brain. When these electrical currents are focused on specific brain regions, pertinent to the neurobiology of AUD it leads to modulation of behavior and plausibly decrease in alcohol craving and use. Previous TMS studies have used heterogenous parameters, including frequencies ranging from 1 Hz to 20 Hz. Regions targeted by these studies encompassed ventromedial prefrontal cortex, left dorsolateral prefrontal cortex (left dlPFC) and right dorsolateral prefrontal cortex. Two studies used a TMS paradigm with greater efficiency than other routine TMS paradigms, called continuous theta burst stimulation. These studies delivered 3600 pulses of cTBS to the left frontal pole/ventromedial prefrontal cortex and showed significant reduction in alcohol cue reactivity and corroborative changes in both resting state and task based functional connectivity. Of these two studies, one was notable in comparing active cTBS (3600 pulses per session, one session every day for ten days over two weeks) versus sham cTBS. A deep TMS (dTMS) study that compared dTMS (15 sessions, five sessions every week for three weeks) to sham dTMS using an H7 coil (targeting medial prefrontal and anterior cingulate cortices). This study showed decreased craving after treatment and percentage of heavy drinking days in the active versus sham control group. Active dTMS was associated with decreased resting-state functional connectivity of the dorsal anterior cingulate cortex with the caudate nucleus and decreased connectivity of the medial prefrontal cortex to the subgenual anterior cingulate cortex. No study has done multiple sessions of cTBS in a single day. In addition, no study has previously delivered cTBS to the left dlPFC, to modulate alcohol craving and alcohol cue based attentional bias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active cTBS and sham cTBS | Experimental | There is only one arm in this study and all participants in this arm will receive 2 interventions: active and sham cTBS in a within subject blinded fashion. They will first receive active cTBS and then sham cTBS, separated by four weeks to minimize carryover effects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active cTBS | Device | Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Penn Alcohol Craving Scale | Craving measured using the Penn alcohol craving scale (PACS) that has five items and is rated on a scale of 1 to 6. Minimum score is 1 and maximum score is 30. Higher score equates to increased craving | Before and after two cTBS sessions, approximately 2 hours |
| Change in Alcohol Cue Attentional Bias | Fixation time on alcohol cues measured using an eye tracker in milliseconds. Higher score indicates greater attentional bias. | Before and after two cTBS sessions, approximately 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Resting State Functional Connectivity | Number of participants with resting state functional connectivity scans acquired before and after cTBS and sham cTBS | Before and after two cTBS sessions, approximately 2 hours |
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Inclusion criteria.
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gopalkumar Rakesh, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 245 Fountain Court | Lexington | Kentucky | 40513 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active cTBS and Sham cTBS | There is only one arm in this study and all participants in this arm will receive 2 interventions: active and sham cTBS in a within subject blinded fashion. They will first receive active cTBS and then sham cTBS, separated by four weeks to minimize carryover effects. Active cTBS: Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes Sham cTBS: Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active cTBS and Sham cTBS | There is only one arm in this study and all participants in this arm will receive 2 interventions: active and sham cTBS in a within subject blinded fashion. They will first receive active cTBS and then sham cTBS, separated by four weeks to minimize carryover effects. Active cTBS: Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes Sham cTBS: Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes |
| 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, Categorical | Count of Participants |
| 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 Penn Alcohol Craving Scale | Craving measured using the Penn alcohol craving scale (PACS) that has five items and is rated on a scale of 1 to 6. Minimum score is 1 and maximum score is 30. Higher score equates to increased craving | Posted | Mean | Standard Deviation | units on a scale | Before and after two cTBS sessions, approximately 2 hours |
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8 weeks
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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 | cTBS and Sham cTBS | All participants received cTBS and sham cTBS in a within-participant design |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gopalkumar Rakesh, MD | University of Kentucky | 8592579402 | 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 | Mar 19, 2025 | Apr 17, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Using the MagVenture A/P coil
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| Sham cTBS | Device | Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Kentucky, United States | Count of Participants | Participants |
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| Primary | Change in Alcohol Cue Attentional Bias | Fixation time on alcohol cues measured using an eye tracker in milliseconds. Higher score indicates greater attentional bias. | Posted | Mean | Standard Deviation | milliseconds | Before and after two cTBS sessions, approximately 2 hours |
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| Secondary | Resting State Functional Connectivity | Number of participants with resting state functional connectivity scans acquired before and after cTBS and sham cTBS | Posted | Count of Participants | Participants | Before and after two cTBS sessions, approximately 2 hours |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| After second session_sham cTBS |
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