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Completed

NCT Number: NCT05631548

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

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

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Key information

Conditions

Cocaine Use Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iTBS to dmPFC

Device

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.

Sham iTBS

Device

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.

Primary outcomes

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

    Time frame: Baseline (before 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 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.

  2. 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.

  3. 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: Baseline (before 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.

  4. 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

  1. Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)

    Time frame: Baseline(before 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.

  2. Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)

    Time frame: 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.

  3. Pain as Assessed by the Visual Analog Scale (VAS)

    Time frame: Baseline(before iTBS session)

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

  4. Pain as Assessed by the Visual Analog Scale (VAS)

    Time frame: Immediately after iTBS session

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

  5. Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  6. Cognitive Function as Assessed by the The Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2022
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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