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Change in staffing at site. Two participants were enrolled. No usable data was collected from these participants.
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The two primary objectives of this study are to test whether intermittent theta-burst (iTBS) can affect behavioral change as compared to treatment as usual (TAU, sham) in individuals with alcohol use disorder (AUD) in inpatient substance use treatment. The secondary objective is to determine whether iTBS reduces the risk for relapse at four months compared to sham. It is hypothesized that individuals who receive iTBS treatment will show attenuated prefrontal cortex (PFC) CNS responses to alcohol related cues and reductions in risk-taking behavior and impulsivity as measured by PFC responses measured by functional near infrared spectroscopy (fNIRs). The proposed approach will be to measure the effect of iTBS treatment on PFC CNS response. Participants will be randomized to receive 5 days (4 x sessions/day x 600 pulses/session = 12,000 pulses) of iTBS or sham to the left dorsal lateral prefrontal cortex (dlPFC) while being exposed to alcohol cues five minutes prior to treatment and during treatment. The investigators will target the Beam/F3 scalp location and use the TMS Navigator Research Premium stereotaxic system for neuronavigation. PFC response data will be gathered using fNIRs measuring cue reactivity, risk-taking (Balloon Analog Risk Test), and impulsiveness (Go No Go task). The primary outcomes will be the mean changes in pre-post PFC response data gathered using the fNIRs sessions. The rationale for this approach is that TBS can be delivered over a shorter time frame than rTMS and may require fewer sessions, allowing for a better fit within a 28-day inpatient treatment stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active iTBS | Experimental | The intermittent theta burst (iTBS) will be delivered using the MagVenture MagPro X100 stimulator equipped with a Cool B-70 A/P (combined active & sham) figure of eight coil. Treatment will be at 100% of MT. Treatment will be approximately 2 ½ minutes long. Each session will be 2-hours in length and consist of four treatments spaced 30 minutes apart. There will be a total of five sessions over the course of five to seven days. |
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| Sham iTBS | Sham Comparator | The B70 A/P coil is also equipped with an active sham electric stimulation (e-stim) system that delivers a small current pulse synchronous to the TMS pulse, titrated to match the TMS sensations. This pulse is similar in duration and distribution to the current induced by the TMS pulse . This pulse will be delivered to the scalp adjacent to the stimulation site via disposable low-profile webbed EEG electrodes filled with electrolytic gel. Electrodes will be connected to the e-stim system via one of two identical cables allowing the operator to deliver either real or sham electric stimulation. Cables will be labeled to match the corresponding coil side so that each session always includes either active TMS or active e-stim, but never both. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | The intermittent theta burst (iTBS) will be delivered using the MagVenture MagPro X100 stimulator equipped with a Cool B-70 A/P (combined active & sham) figure of eight coil. MagVenture MagPro X100 is available commercially and has been FDA approved to treat major depressive disorder and obsessive-compulsive disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| Cue-evoked prefrontal cortex activity | Individuals will undergo a cue reactivity task composed of four stimulus categories: general alcohol cues; alcohol cues specific to patient alcohol choice preferences; natural reward cues; and emotionally neutral cues (e.g., pictures of everyday objects like lamps, pens) will be monitored with Functional near-infrared spectroscopy (fNIRS) over the prefrontal cortex. fNIRS measures the amount of infrared light absorbed by the brain, which differs as a function of ongoing brain activity. The magnitude of this signal (absorption factor) will be calculated for the conditions described above. | 24 hours before first iTBS session and 24 hours after last iTBS session |
| Measure | Description | Time Frame |
|---|---|---|
| Risk-taking | The Balloon Analog Risk Task (BART) will be used to measure risk-taking behavior. Participants are presented with virtual balloons that they must blow up, but not pop. The more they fill their virtual balloons, the greater the reward. However, if the balloon pops, they lose their rewards. The primary measure of this task it the average number of pumps per balloon, which is a measure of their risk-taking behavior. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caron Treatment Centers | Wernersville | Pennsylvania | 19565 | United States |
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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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| 24 hours before first iTBS session and 24 hours after last iTBS session |
| Impulsiveness | The Go/No Go task will be used to measure impulsiveness. Participants are given a series of trials where they are required to respond to the go stimuli and withhold a response to the no-go stimuli. Performance on this task will be assessed by comparing their accuracy on the go trials to their accuracy on the no-go trials using d-prime (Hits - False alarms), which is associated with impulsive responding on the no-go trials. | 24 hours before first iTBS session and 24 hours after last iTBS session |