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Clinical Trials/NCT05631548
NCT05631548
Completed
Not Applicable

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

The University of Texas Health Science Center, Houston1 site in 1 country6 target enrollmentFebruary 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cocaine Use Disorder
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
6
Locations
1
Primary Endpoint
Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 23, 2023
End Date
August 2, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heather E. Webber, PhD

Instructor

The University of Texas Health Science Center, Houston

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

Outcomes

Primary Outcomes

Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG

Time Frame: Immediately after iTBS session

The Doors Task will be used to elicit the Reward Potential (RewP) component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up (win) or if they did not find the prize by a red arrow pointing down (loss). The amplitude of the RewP in microvolts in response to feedback is reported.

Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG

Time Frame: Immediately after iTBS session

The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and cocaine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.

Secondary Outcomes

  • Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)(Immediately after iTBS session)
  • Cognitive Function as Assessed by the The Montreal Cognitive Assessment (MoCA)(Immediately after iTBS session)
  • Pain as Assessed by the Visual Analog Scale (VAS)(Immediately after iTBS session)
  • Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)(Baseline(before iTBS session))

Study Sites (1)

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