Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT05986578
Status
Recruiting
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Conditions

  • Cocaine Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS 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. For dmPFC, 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) 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 \~3 minutes. The stimulation will start at a lower percentage and ramp up over time to acclimate participant to the feeling of stimulation. The intensity will be lowered in participant cannot tolerate the stimulation. Each participant will receive 3 sessions per visit with a 15-20 minute interval between sessions to increase the likelihood of detecting acute effects.
  • TMS to dlPFC — 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. For dlPFC, position F3 will be measured, using probabilistic EEG placement. The first session will begin with the acquisition of the resting motor threshold 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 3 minutes. The stimulation will start at a lower percentage and ramp up over time to acclimate participant to the feeling of stimulation. The intensity will be lowered in participant cannot tolerate the stimulation. Each participant will receive 3 sessions per visit with a 15-20 minute interval between sessions to increase the likelihood of detecting acute effects.
  • 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 3 sessions with a 15-20 min interval between sessions.

Study Details

The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder.

Key Dates

Start date
Nov 8, 2024
Status verified
May 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: dlPFC then dmPFC then Sham iTBS
  • Experimental: dmPFC then dlPFC then sham iTBS
  • Experimental: dmPFC then sham iTBS then dlPFC
  • Experimental: dlPFC then sham iTBS then dmPFC
  • Experimental: sham iTBS then dlPFC then dmPFC
  • Experimental: shami iTBS then dmPFC then dl PFC

Primary Outcome Measure

Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task [ Time Frame: Baseline(before iTBS session),immediately after iTBS session ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Heather Webber, PhD
[email protected]
713-486-2723
Jessica Vincent
[email protected]
713-486-2645

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By research site
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