Depressive DisorderNCT04016402
Imaging to Improve Brain Stimulation
An observational study of Depressive Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This study investigates how brains change as a result of a treatment for depression called repetitive transcranial magnetic stimulation (rTMS). People who receive rTMS will have pictures of their brains and brain activity taken by a magnetic resonance imaging (MRI) scanner before and after their treatment, as well as… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans who receive TMS therapy for the treatment of MDD at the Providence VAMC Neuromodulation Clinic
Who may be able to join
- Veteran beginning TMS therapy for the treatment of MDD at the Providence VAMC Neuromodulation Clinic
- Age between 18 and 80 years
- Able to read, verbalize, understand, and voluntarily sign the informed consent form
- Structured Clinical Interview for DSM-5 (SCID-5) confirmed diagnosis of MDD
Who cannot join
- Contraindications to MRI (e.g. implanted metal or electronic devices)
- Montreal Cognitive Assessment (MoCA) score < 26
- Pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
About this study
Official title: Targeting Functional Improvement in rTMS Therapy
This study investigates how brains change as a result of a treatment for depression called repetitive transcranial magnetic stimulation (rTMS). People who receive rTMS will have pictures of their brains and brain activity taken by a magnetic resonance imaging (MRI) scanner before and after their treatment, as well as up to three times during the six-week treatment course. These images will be examined to see if the rTMS is placed correctly to help treat their symptoms, and what changes in brain activity are happening during the rTMS treatment
Read the detailed description
Veteran patients can be referred to receive a Neuromodulation Clinic consult at the Providence VA Medical Center (PVAMC). Following this consultation, patients who are to begin rTMS therapy for the treatment of major depressive disorder (MDD) will be recruited to participate in this study. About 1 week prior to the scheduled beginning of rTMS therapy, research participants who provide informed consent will complete baseline neuropsychological measures. Within a few days of completing these measures, and before beginning rTMS therapy, participants will receive an MRI scan, including structural and functional imaging. Participants will have a similar set of MRI scans up to three times during the course of rTMS therapy, and complete neuropsychological measures at these scanning sessions. A final MRI scan will be conducted within a week of completing the rTMS therapy course, and neuropsychological measures will be completed at this session.
- Conditions
- Depressive Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Transcranial Magnetic Stimulation, Magnetic Resonance Imaging
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called transcranial magnetic stimulation, theta burst transcranial magnetic stimulation
Clinical transcranial magnetic stimulation administered as part of usual care for the study population
| Study group | Role | What they receive |
|---|---|---|
| Study Group | All participants enrolled in the study Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between treatment location and brain target
A marker visible on MRI will be placed on the treatment location for the MRI scan after treatment completion. Functional MRI will be used to localize the dorsolateral prefrontal cortex (DLPFC), the brain region targeted by rTMS. The distance between these two points will be calculated for each participant.
Measured: Within one week of the conclusion of clinical rTMS therapy course
Secondary outcomes (5)
World Health Organization Disability Assessment Schedule 2.0 36-item version
Scores from the World Health Organization Disability Assessment Schedule 36-item version (WHODAS-36). Self-assessment of global functioning, with scores ranging from 0 (no disability) to 100 (full disability).
Measured: Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course
Inventory of Depressive Symptoms Self-Report
Scores from the Inventory of Depressive Symptoms Self-Report (IDS-SR). A 30-item self-assessment of depressive symptoms with scores ranging from 0 (no depressive symptoms) to 90 (severe depression).
Measured: Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course
Patient Health Questionnaire 9-item
Scores from the Patient Health Questionnaire, 9-item version (PHQ-9). A self-assessment of depressive symptoms with scores ranging from 0 (no depressive symptoms) to 27 (severe depression).
Measured: Within one week before beginning the clinical rTMS therapy course, and weekly during the clinical rTMS therapy course (typically 6 weeks), including the last day of treatment
Post-Traumatic Stress Disorder Checklist for DSM-5
Scores from the Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5). A self-assessment of PTSD symptoms with scores ranging from 0 (no PTSD symptoms) to 80 (severe PTSD symptoms)
Measured: Within one week before beginning the clinical rTMS therapy course, and weekly during the clinical rTMS therapy course (typically 6 weeks), including the last day of treatment
Veteran's RAND 36-item
Scores from the Veteran's RAND 36-item (VR-36). Assessment of self-reported health quality of life. Includes physical and mental component normed subscores (x=50, sd=10) ranging from 0 (worst health) to 100 (best health).
Measured: Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start24 Oct 2019
- Primary completion30 Sep 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Palo Alto Health Care System, Brown University
- Responsible party
- Sponsor
- Investigators
- Allyson C Rosen, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CANoah S. Philip, MD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016402
- Sponsor's protocol ID
- D3152-R-1
- Other IDs
- N2864-C
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2019
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Functional Improvement in rTMS Therapy
- ClinicalTrials.gov ID
- NCT04016402
- Acronym / sponsor ID
- D3152-R-1
- Conditions
- Depressive Disorder
- Keywords
- Transcranial Magnetic Stimulation, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Palo Alto Health Care System, Brown University
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 11 Jul 2019 (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.
This study investigates how brains change as a result of a treatment for depression called repetitive transcranial magnetic stimulation (rTMS). People who receive rTMS will have pictures of their brains and brain activity taken by a magnetic resonance imaging (MRI) scanner before and after their treatment, as well as up to three times during the six-week treatment course. These images will be examined to see if the rTMS is placed correctly to help treat their symptoms, and what changes in brain activity are happening during the rTMS treatment
Detailed description
Veteran patients can be referred to receive a Neuromodulation Clinic consult at the Providence VA Medical Center (PVAMC). Following this consultation, patients who are to begin rTMS therapy for the treatment of major depressive disorder (MDD) will be recruited to participate in this study. About 1 week prior to the scheduled beginning of rTMS therapy, research participants who provide informed consent will complete baseline neuropsychological measures. Within a few days of completing these measures, and before beginning rTMS therapy, participants will receive an MRI scan, including structural and functional imaging. Participants will have a similar set of MRI scans up to three times during the course of rTMS therapy, and complete neuropsychological measures at these scanning sessions. A final MRI scan will be conducted within a week of completing the rTMS therapy course, and neuropsychological measures will be completed at this session.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants enrolled in the study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans who receive TMS therapy for the treatment of MDD at the Providence VAMC Neuromodulation Clinic
Key inclusion criteria (4 listed)
- Veteran beginning TMS therapy for the treatment of MDD at the Providence VAMC Neuromodulation Clinic
- Age between 18 and 80 years
- Able to read, verbalize, understand, and voluntarily sign the informed consent form
- Structured Clinical Interview for DSM-5 (SCID-5) confirmed diagnosis of MDD
Key exclusion criteria (3 listed)
- Contraindications to MRI (e.g. implanted metal or electronic devices)
- Montreal Cognitive Assessment (MoCA) score < 26
- Pregnant
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Also: transcranial magnetic stimulation, theta burst transcranial magnetic stimulationClinical transcranial magnetic stimulation administered as part of usual care for the study population | Device | Study Group |
Primary outcome
Distance between treatment location and brain target
Time frame: Within one week of the conclusion of clinical rTMS therapy course
A marker visible on MRI will be placed on the treatment location for the MRI scan after treatment completion. Functional MRI will be used to localize the dorsolateral prefrontal cortex (DLPFC), the brain region targeted by rTMS. The distance between these two points will be calculated for each participant.
5 secondary outcomes
World Health Organization Disability Assessment Schedule 2.0 36-item version
Time frame: Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course
Inventory of Depressive Symptoms Self-Report
Time frame: Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course
Patient Health Questionnaire 9-item
Time frame: Within one week before beginning the clinical rTMS therapy course, and weekly during the clinical rTMS therapy course (typically 6 weeks), including the last day of treatment
Post-Traumatic Stress Disorder Checklist for DSM-5
Time frame: Within one week before beginning the clinical rTMS therapy course, and weekly during the clinical rTMS therapy course (typically 6 weeks), including the last day of treatment
Veteran's RAND 36-item
Time frame: Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Allyson C Rosen, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
Noah S. Philip, MD principal investigator
Providence VA Medical Center, Providence, RI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, run by VA Office of Research and Development at 2 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between treatment location and brain target (time frame: Within one week of the conclusion of clinical rTMS therapy course). 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 3 Aug 2026.