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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01RD000693-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
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The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. This placebo controlled study will test the effectiveness of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Experimental | Receive active rTMS |
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| Sham rTMS | Sham Comparator | Receive sham rTMS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) | Device | rTMS is a non-invasive procedure in which administering a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention (active and sham) will be administered in 30 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Relapsed | Rate of stimulant use relapse compared between active vs. sham rTMS groups | 3 months after last rTMS treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Reward circuit function and signaling | Before and after treatment, participants will undergo functional magnetic resonance imaging (fMRI) imaging while completing the Monetary Incentive Delay Task, a validated probe of reward processing circuit function and dysfunction. Signaling in the substantia nigra will be measured in an individual-subject, "native space" region of interest approach as a marker of dopaminergic reward processing function, as well as in voxel-wise, whole-brain exploratory analyses. Changes in reward function and signaling will be compared between active vs. sham rTMS groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong H Yoon, MD | Contact | (650) 493-5000 | jhyoon1@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jong H. Yoon, MD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | United States |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Participants will be randomly assigned to one of two groups to receive active or sham rTMS.
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This is a double-blind study in which participants, staff administering treatment, investigators, and outcome assessors are all masked to group assignments.
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| Sham rTMS | Device | Subjects randomized to sham rTMS will undergo the same procedures on the same equipment as subjects assigned to active rTMS, but no active magnetic stimulation will be delivered. |
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| Within 1 week before rTMS treatment and within 1 week after rTMS treatment |