Targeting EEG Markers With TMS in Cocaine Use Disorder

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05631548
Collaborator
(none)
5
1
2
9.2
0.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: iTBS to dmPFC
  • Device: Sham iTBS
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Basic Science
Official Title:
Targeting Physiological Markers of Reward Functioning With Transcranial Magnetic Stimulation in Cocaine Use Disorder
Anticipated Study Start Date :
Jan 25, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in the amplitude of the Reward Potential (RewP) in microvolts in response to feedback on the Doors Task as assessed by the EEG [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.

  2. 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 [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 Outcome Measures

  1. Change in craving as assessed by the Minnesota Cocaine Craving Scale (MCCS) [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.

  2. Change in pain as assessed by the Visual Analog Scale (VAS) [Baseline(before iTBS session),immediately after iTBS session]

    This is scored from 1(no pain) to 10 (worst pain)

  3. Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heather E. Webber, PhD, Instructor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05631548
Other Study ID Numbers:
  • HSC-MS-21-0813 (pilot study)
First Posted:
Nov 30, 2022
Last Update Posted:
Jan 17, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Heather E. Webber, PhD, Instructor, The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2023