Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder (Pilot Study)
Purpose
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
Eligibility
- Eligible Ages
-
Between 18 Years and 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
-
No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Care Provider)
Arm Groups
Arm | Description | Assigned Intervention |
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.
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center, Houston
Study Contact