Clinical trial NCT05631548: Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder (Pilot Study)
Official title: Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Use Disorder
Keywords: Transcranial Magnetic Stimulation (TMS)
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the effects of active intermittent theta burst stimulation (iTBS) to dorsomedial prefrontal cortex (dmPFC) on electroencephalogram (EEG) measures of reward sensitivity and cue reactivity and cocaine craving in cocaine users


Eligibility criteria: Inclusion Criteria:

* CUD diagnosis

Exclusion Criteria:

* moderate or severe criteria for substances other than cocaine, cannabis, or nicotine
* unstable psychiatric disorder
* medical conditions contraindicated to TMS (e.g., medical implants, history of seizure or seizure disorder, medications lowering the seizure threshold, neurological conditions, moderate-to-severe heart disease)
* pregnancy
* hairstyles incompatible with the EEG net
* head injury with loss of consciousness

Primary outcomes:
measure: Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG
timeFrame: Baseline (before iTBS session)
measure: Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG
timeFrame: Immediately after iTBS session
measure: Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG
timeFrame: Baseline (before iTBS session)
measure: Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG
timeFrame: Immediately after iTBS session
Secondary outcomes:
measure: Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)
timeFrame: Baseline(before iTBS session)
measure: Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)
timeFrame: Immediately after iTBS session
measure: Pain as Assessed by the Visual Analog Scale (VAS)
timeFrame: Baseline(before iTBS session)
measure: Pain as Assessed by the Visual Analog Scale (VAS)
timeFrame: Immediately after iTBS session
measure: Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline(before iTBS session)
measure: Cognitive Function as Assessed by the The Montreal Cognitive Assessment (MoCA)
timeFrame: Immediately after iTBS session
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Heather Webber, PhD
role: PRINCIPAL_INVESTIGATOR
References: