Clinical trial NCT06060496: Theta Burst Stimulation for Alcohol Use Disorder
Official title: Theta Burst Stimulation for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Transcranial magnetic stimulation (TMS)
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-09-29
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion criteria.

* Patients seen at a clinic within the University of Kentucky Healthcare
* 21-60 years of age
* male or female gender
* Able to read, understand and communicate in English
* willing to adhere to the general rules of the UK Healthcare
* Must fulfill criteria for moderate alcohol use disorder.

Exclusion criteria

* Positive pregnancy test for females
* traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia
* intracranial metal shrapnel
* previous adverse effect with TMS
* sub-threshold consistency while performing behavioral tasks
* failure to show baseline attentional bias to alcohol versus neutral cues.

Primary outcomes:
measure: Change in Penn Alcohol Craving Scale
timeFrame: Before and after two cTBS sessions, approximately 2 hours
measure: Change in Alcohol Cue Attentional Bias
timeFrame: Before and after two cTBS sessions, approximately 2 hours
Secondary outcomes:
measure: Resting State Functional Connectivity
timeFrame: Before and after two cTBS sessions, approximately 2 hours
Other outcomes:
Locations:
city: Lexington
country: United States
facility: 245 Fountain Court
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Gopalkumar Rakesh, PhD
role: PRINCIPAL_INVESTIGATOR
References: