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In this pilot study, investigators propose to design and create a portable TMS unit, in a van, and then test out delivering TMS in three different locations in South Carolina, all affiliated with MUSC and within 2-hours driving from Charleston, SC. This study would test out this new delivery mode, and provide valuable feasibility, safety, and efficacy lessons for later refinement and potential widespread adoption of mobile TMS as a treatment option, both in our state and across the US.
In this pilot study, investigators propose to design and create a portable TMS unit, in a van, and then test out delivering TMS in three different locations in South Carolina, all within 90 minutes driving from Charleston, SC. This study would test out this new delivery mode, and provide valuable lessons for later refinement and potential widespread adoption of mobile TMS as a treatment option. This would open up access to TMS for millions of patients with treatment resistant depression who cannot be treated in the current model. After this pilot feasibility and efficacy study, future research would use mobile TMS units for siting at residential care facilities, or remote hospitals and clinics.
Investigators aim to determine whether it is possible to assemble and build a functioning mobile TMS unit. After assembling the van, investigators will then recruit up to 30 treatment-resistant depression patients who live near one of three satellite MUSC clinics. These clinics are all within a 2 hour drive from the MUSC Charleston campus. Investigators will treat these patients, open label, with FDA approved accelerated TMS (6 sessions each day, over 2 hours, for 5 days, spread over one or two weeks). Investigators will measure TMS effectiveness using standard depression rating scales. Importantly, investigators will also collect the costs of performing the TMS which will inform whether MUSC or other health delivery systems might adopt this TMS method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label Clinical TMS for Depression | Other | This will be FDA approved Left Prefrontal TMS for treating depression, we will be performing this within a VA, located at clinics throughout SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left prefrontal Transcranial Magnetic Stimulation (TMS) | Device | FDA cleared TMS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of depression responders | Number of patients with >50% improvement in Phq-9 scores before and then after 5 days of treatment | From baseline to 1 week immediately after treatment week |
| Improvement in Depression Symptoms | Change in Phq-9 ratings from baseline to end of treatment | From baseline to 1 week immediately after treatment week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark S George, MD | Contact | 8438765142 | GEORGEM@MUSC.EDU | |
| Alexandra Herron, BA | Contact | herronal@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark George, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Univerity of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
age, gender, degree of treatment resistance, current medications, changes in depression scores
After conclusion of the study and for 5 years after publication.
All credible investigators, by writing and asking permission from the study PI and team.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Mobile TMS qualifies as a Phase IV trial because it assesses the real-world efficacy of TMS therapy when administered via a mobile unit.
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| FDA cleared TMS for treating depression | Device | This is FDA approved TMS |
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