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

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

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

Study Overview

• Status: Completed
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Device: iTBS to dmPFC; Device: Sham iTBS

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iTBS to dmPFC, Then Sham iTBS	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.
Sham Comparator: Sham iTBS, Then iTBS to dmPFC	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG	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 or if they did not find the prize by a red arrow pointing down. The amplitude of the RewP in microvolts in response to feedback is reported.	Baseline (before iTBS session)
Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG	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.	Immediately after iTBS session
Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG	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.	Baseline (before iTBS session)
Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG	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.	Immediately after iTBS session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)	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.	Baseline(before iTBS session)
Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)	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.	Immediately after iTBS session
Pain as Assessed by the Visual Analog Scale (VAS)	This is scored from 0(no pain) to 10 (worst pain), higher score indicating greater pain.	Baseline(before iTBS session)
Pain as Assessed by the Visual Analog Scale (VAS)	This is scored from 0(no pain) to 10 (worst pain), higher score indicating greater pain.	Immediately after iTBS session
Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)	Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.	Baseline(before iTBS session)
Cognitive Function as Assessed by the The Montreal Cognitive Assessment (MoCA)	Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.	Immediately after iTBS session

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Heather Webber, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): August 2, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation (TMS)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: HSC-MS-21-0813 (pilot study)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No