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Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder (Pilot Study)

Not Applicable
Completed
Conditions
Cocaine Use Disorder
Interventions
Device: iTBS to dmPFC
Device: Sham iTBS
Registration Number
NCT05631548
Lead Sponsor
The University of Texas Health Science Center, Houston
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
iTBS to dmPFC, Then Sham iTBSiTBS to dmPFC-
iTBS to dmPFC, Then Sham iTBSSham iTBS-
Sham iTBS, Then iTBS to dmPFCiTBS to dmPFC-
Sham iTBS, Then iTBS to dmPFCSham iTBS-
Primary Outcome Measures
NameTimeMethod
Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEGImmediately 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 EEGImmediately 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 Outcome Measures
NameTimeMethod
Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)Immediately after iTBS session

The first question (intensity of craving) will be used and is measured from 0(none, not at all) to 100(a great deal), higher number indicating more craving.

Cognitive Function as Assessed by the The Montreal Cognitive Assessment (MoCA)Immediately after iTBS session

Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.

Pain as Assessed by the Visual Analog Scale (VAS)Immediately after iTBS session

This is scored from 0(no pain) to 10 (worst pain), higher score indicating greater pain.

Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)Baseline(before iTBS session)

Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston

🇺🇸

Houston, Texas, United States

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