An interventional study of Active cTBS and Sham cTBS in Alcohol Use Disorder, sponsored by Gopalkumar Rakesh. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Gopalkumar Rakesh · Not applicable, Interventional, and Treatment
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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This study's enrollment of 8 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
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Exclusion criteria
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.
Device: Active cTBS · Device: Sham cTBS
Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes
Also known as: Continuous theta burst stimulation
Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes
Also known as: Continuous theta burst stimulation
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
Time frame: 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.
Time frame: Before and after two cTBS sessions, approximately 2 hours
Resting State Functional Connectivity
Number of participants with resting state functional connectivity scans acquired before and after cTBS and sham cTBS
Time frame: Before and after two cTBS sessions, approximately 2 hours
| Milestone | Active cTBS and Sham cTBS |
|---|---|
| Started | 8 |
| Completed | 4 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 2 |
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
| units on a scale | cTBS and Sham cTBS |
|---|---|
| Baseline_cTBS | 11.50 ± 9.68 |
| After second session_cTBS | 11.75 ± 9.43 |
| Baseline_sham cTBS | 8.25 ± 5.44 |
| After second session_sham cTBS | 7.25 ± 6.70 |
Fixation time on alcohol cues measured using an eye tracker in milliseconds. Higher score indicates greater attentional bias.
| milliseconds | cTBS and Sham cTBS |
|---|---|
| Baseline_cTBS | 294.92 ± 667.18 |
| After second session_cTBS | 459.60 ± 1618.57 |
| Baseline_sham cTBS | 355.3 ± 659.06 |
| After second session_sham cTBS | 666.30 ± 1592.36 |
Number of participants with resting state functional connectivity scans acquired before and after cTBS and sham cTBS
| Participants | Active cTBS and Sham cTBS |
|---|---|
| Resting State Functional Connectivity | 4 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| cTBS and Sham cTBS | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Active cTBS and Sham cTBS |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Age, Continuous(years) | Active cTBS and Sham cTBS |
|---|---|
| Mean | 41 ± 11.7 |
| Sex: Female, Male(Participants) | Active cTBS and Sham cTBS |
|---|---|
| Female | 4 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Active cTBS and Sham cTBS |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Active cTBS and Sham cTBS |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Active cTBS and Sham cTBS |
|---|---|
| United States | 8 |
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Gopalkumar Rakesh