NCT05631548

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

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cocaine Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-23
• Primary completion: 2023-08-02
• Completion: 2023-08-02
• First posted: 2022-11-30
• Last updated: 2024-01-31
• Results posted: 2024-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study