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

Keywords

• Transcranial Magnetic Stimulation (TMS)

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Study arms

• Experimental
  iTBS to dmPFC, Then Sham iTBS

  Device: iTBS to dmPFC · Device: Sham iTBS

• Sham comparator
  Sham iTBS, Then iTBS to dmPFC

  Device: iTBS to dmPFC · Device: Sham iTBS

Interventions

• DeviceiTBS 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.

• DeviceSham 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.

Primary outcomes

1. 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.

   Time frame: Baseline (before iTBS session)

2. 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.

   Time frame: Immediately after iTBS session

3. 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.

   Time frame: Baseline (before iTBS session)

4. 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.

   Time frame: Immediately after iTBS session

Secondary outcomes

1. 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.

   Time frame: Baseline(before iTBS session)

2. 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.

   Time frame: Immediately after iTBS session

3. 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.

   Time frame: Baseline(before iTBS session)

4. 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.

   Time frame: Immediately after iTBS session

5. 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.

   Time frame: Baseline(before iTBS session)

6. 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.

   Time frame: Immediately after iTBS session

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Sep 11, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No