Targeting EEG Markers With TMS in Cocaine Use Disorder

Overview

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

Full Title of Study: “Targeting Physiological Markers of Reward Functioning With Transcranial Magnetic Stimulation in Cocaine Use Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: October 31, 2023

Interventions

  • Device: iTBS to dmPFC
    • TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. Approximately 25% of the nasion-inion distance, or Talairah coordinates X 0 Y+60 Z+60 will be measured.The first session will begin with the acquisition of the resting motor threshold (rMT; lowest stimulus intensity that elicits a visible twitch on 50% of the trials) on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last about 3 minutes. Each participant will receive 2 sessions with a 15-20 minute interval between sessions.
  • Device: Sham iTBS
    • Sham TMS will be delivered with the sham side of the MagVenture Cool B70 A/P coil. The software will be pre-programmed by a staff member that will not be involved in data analysis or collection for blinding purposes. The sham stimulation will match the number of pulses and length of time as the active condition and each participant will receive 2 sessions with a 15-20 min interval between sessions.

Arms, Groups and Cohorts

  • Experimental: iTBS to dmPFC, Then Sham iTBS
  • Sham Comparator: Sham iTBS, Then iTBS to dmPFC

Clinical Trial Outcome Measures

Primary Measures

  • Change in the amplitude of the Reward Potential (RewP) in microvolts in response to feedback on the Doors Task as assessed by the EEG
    • Time Frame: Baseline(before iTBS session),immediately after iTBS session
    • The Doors Task will be used to elicit the 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 or if they did not find the prize by a red arrow pointing down.
  • Change in the amplitude of the late positive potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task as assessed by the EEG
    • Time Frame: Baseline(before iTBS session),immediately after iTBS session
    • The Picture Viewing Task will be used to elicit the 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.

Secondary Measures

  • Change in craving as assessed by the Minnesota Cocaine Craving Scale (MCCS)
    • Time Frame: Baseline(before iTBS session),immediately after iTBS session
    • The first question (intensity of craving) will be used and is measured from 1(none, not at all) to 10(a great deal), higher number indicating more craving.
  • Change in pain as assessed by the Visual Analog Scale (VAS)
    • Time Frame: Baseline(before iTBS session),immediately after iTBS session
    • This is scored from 1(no pain) to 10 (worst pain)
  • Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA)
    • Time Frame: Baseline(before iTBS session),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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Heather E. Webber, PhD, Instructor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Heather Webber, PhD, Principal Investigator, The University of Texas Health Science Center, Houston
  • Overall Contact(s)
    • Heather Webber, PhD, 713-486-2723, Heather.E.Webber@uth.tmc.edu

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