Treatment Resistant Major DepressionPhase 4TMSNCT06748209
Establishing Mobile Transcranial Magnetic Stimulation
A Phase 4 study testing Left prefrontal Transcranial Magnetic Stimulation (TMS) and FDA cleared TMS for treating depression in people with Treatment Resistant Major Depression, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Treatment Resistant Major Depression
- What is being tested?
- Left prefrontal Transcranial Magnetic Stimulation (TMS) and FDA cleared TMS for treating depression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2025to 1 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (22-80 years old)
- Have treatment-resistant depression as defined by the e-Mini, and the antidepressant treatment history form (ATHF short).
- Be able to read and communicate in English.
- Able to provide their own consent.
- Access to a computer with videoconferencing ability for initial consent and telescreen.
Who cannot join
- Patients with unstable medical conditions that might make TMS unsafe. This includes current poorly controlled seizures.
- Ferromagnetic metal in the head.
- Pregnant.
- Currently active substance abuse except tobacco.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandra Herron, BA contact
United States1 site, 1 recruiting
- Recruiting
Medical Univerity of South Carolina
Charleston, South Carolina, 29425
Mark S. George, MD, 8438765142, GEORGEM@MUSC.EDU
About this study
Official title: Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression
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.
Read the detailed description
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.
- Conditions
- Treatment Resistant Major Depression
- Being tested
- Left prefrontal Transcranial Magnetic Stimulation (TMS), FDA cleared TMS for treating depression
- Keywords
- Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left prefrontal Transcranial Magnetic Stimulation (TMS)Device
FDA cleared TMS
FDA cleared TMS for treating depressionDevice
This is FDA approved TMS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Left prefrontal Transcranial Magnetic Stimulation (TMS); Device: FDA cleared TMS for treating depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of depression responders
Number of patients with >50% improvement in Phq-9 scores before and then after 5 days of treatment
Measured: From baseline to 1 week immediately after treatment week
Improvement in Depression Symptoms
Change in Phq-9 ratings from baseline to end of treatment
Measured: From baseline to 1 week immediately after treatment week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start10 May 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mobile TMS qualifies as a Phase IV trial because it assesses the real-world efficacy of TMS therapy when administered via a mobile unit.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark George, Medical University of South Carolina
- Investigators
- Mark George, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748209
- Sponsor's protocol ID
- Pro00139739
- Acronym
- TMS
- Status last verified
- May 2026
- First submitted
- 19 Dec 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: age, gender, degree of treatment resistance, current medications, changes in depression scores
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT06748209
- Acronym / sponsor ID
- TMS / Pro00139739
- Conditions
- Treatment Resistant Major Depression
- Keywords
- Anxiety, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mobile TMS qualifies as a Phase IV trial because it assesses the real-world efficacy of TMS therapy when administered via a mobile unit.
| Arm | Type | Receives |
|---|---|---|
| Open label Clinical TMS for Depression | Other | Device: Left prefrontal Transcranial Magnetic Stimulation (TMS), Device: FDA cleared TMS for treating depressionThis will be FDA approved Left Prefrontal TMS for treating depression, we will be performing this within a VA, located at clinics throughout SC. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (22-80 years old)
- Have treatment-resistant depression as defined by the e-Mini, and the antidepressant treatment history form (ATHF short).
- Be able to read and communicate in English.
- Able to provide their own consent.
- Access to a computer with videoconferencing ability for initial consent and telescreen.
Key exclusion criteria (4 listed)
- Patients with unstable medical conditions that might make TMS unsafe. This includes current poorly controlled seizures.
- Ferromagnetic metal in the head.
- Pregnant.
- Currently active substance abuse except tobacco.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left prefrontal Transcranial Magnetic Stimulation (TMS)FDA cleared TMS | Device | Open label Clinical TMS for Depression |
| FDA cleared TMS for treating depressionThis is FDA approved TMS | Device | Open label Clinical TMS for Depression |
Primary outcome
Percent of depression responders
Time frame: From baseline to 1 week immediately after treatment week
Number of patients with >50% improvement in Phq-9 scores before and then after 5 days of treatment
Improvement in Depression Symptoms
Time frame: From baseline to 1 week immediately after treatment week
Change in Phq-9 ratings from baseline to end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. age, gender, degree of treatment resistance, current medications, changes in depression scores
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Herron, BA contact
Mark George, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Left prefrontal Transcranial Magnetic Stimulation (TMS) and FDA cleared TMS for treating depression in people with Treatment Resistant Major Depression, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark S George, MD (8438765142, GEORGEM@MUSC.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of depression responders (time frame: From baseline to 1 week immediately after treatment week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.