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| ID | Type | Description | Link |
|---|---|---|---|
| 54458 | Other Identifier | Stanford University |
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COVID-19 pandemic adversely affected recruitment.
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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. rTMS may be a promising treatment option for SUD. In this study, we will demonstrate the feasibility of applying rTMS to Veterans with SUD, examine the efficacy 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 |
|
| Sham rTMS | Sham Comparator | Receive sham rTMS |
|
| 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 8 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 underwent 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 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 compared between active vs. sham rTMS groups |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating female
History of prior adverse reaction to TMS
On medications thought to significantly lower seizure threshold, e.g.:
Use of direct dopaminergic antagonists or agonists
History of seizures or conditions known to substantially increase risk for seizures
Implants or medical devices incompatible with TMS
Acute or unstable chronic medical illness that would affect participation or compliance with study procedures, e.g. unstable angina
Unstable psychiatric symptoms that precludes consistent participation in the study, e.g.:
Inability to undergo fMRI scan, e.g. claustrophobia, presence of ferromagnetic objects in subject's body
Other substance use disorder not in sustained remission
Chronic or recurring Axis I psychiatric condition preceding SUD other than PTSD
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| 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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8 people did not enter intervention phase. Defining drop out as those who started the intervention and dropped out before completing intervention & outcome measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active rTMS | Receive active rTMS Repetitive transcranial magnetic stimulation (rTMS): rTMS is a non-invasive procedure which administers a transient magnetic field inducing electrical currents in specific, targeted brain regions. The intervention was administered in 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex. |
| FG001 | Sham rTMS | All subjects underwent the same procedure as the active rTMS group except that the inactive side of the coil was placed on the subject's scalp. The experience receiving sham rTMS was identical except that no electrical current was administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data is only available for participants who completed intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Active rTMS | Receive active rTMS Repetitive transcranial magnetic stimulation (rTMS): rTMS is a non-invasive procedure which administers a transient magnetic field inducing electrical currents in specific, targeted brain regions. The intervention was administered in 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Relapsed | Rate of stimulant use relapse compared between active vs. sham rTMS groups | Posted | Count of Participants | Participants | 3 months after last rTMS treatment |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active rTMS | Receive active rTMS Repetitive transcranial magnetic stimulation (rTMS): rTMS is a non-invasive procedure which administers a transient magnetic field inducing electrical currents in specific, targeted brain regions. The intervention was administered in 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex. |
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COVID-19 pandemic adversely affected recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jong Yoon | Palo Alto VA | 6504935000 | jong.yoon@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2025 | Apr 28, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2025 | Apr 28, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2023 | Nov 26, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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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|
| Within 1 week before and after rTMS treatment |
| BG001 |
| Sham rTMS |
All subjects underwent the same procedure as the active rTMS group except that the inactive side of the coil was placed on the subject's scalp. The experience receiving sham rTMS was identical except that no electrical current was administered. |
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Reward Circuit Function and Signaling | Before and after treatment, participants underwent 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 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 compared between active vs. sham rTMS groups | Unable to conduct this portion of study due to COVID-19 pandemic related logistical challenges. Data will never be collected in the future. | Posted | Within 1 week before and after rTMS treatment |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Sham rTMS | All subjects underwent the same procedure as the active rTMS group except that the inactive side of the coil was placed on the subject's scalp. The experience receiving sham rTMS was identical except that no electrical current was administered. | 0 | 11 | 0 | 11 | 0 | 11 |
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