DepressionNCT05008198
Assessing an EEG Biomarker of Response to TMS for Major Depression
An observational study of Depression, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans with treatment resistant depression (TRD) have the opportunity to receive transcranial magnetic stimulation (TMS) treatment via the VA's National TMS Clinical Pilot Program. While some see improvement with their depression, others do not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial Magnetic Stimulation
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 30 Sep 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans with major depressive disorder (MDD) participating in the VA Clinical TMS Pilot Program. Given the complex nature of the Veteran population, the primary diagnosis of MDD may be comorbid with other disorders, including post-traumatic stress disorder (PTSD).
Who may be able to join
- Veterans participating in the VA TMS Pilot Program age 18 years or older
- Able to provide written informed consent to participate in the EEG portion of this study and to allow linking such data to data collected as part of the TMS Pilot Program
- Diagnosis of MDD based on DSM-5 criteria and be currently depressed despite prior treatment with at least one adequate antidepressant treatment
- Receiving stable doses of psychiatric medications (no dose changes for >4 weeks prior to study entry), in stable psychotherapy, or receiving no psychiatric medications and/or psychotherapy
Who cannot join
- History of seizure disorder
- Known structural or neurologic abnormalities present or close to the treatment site that would increase risk of seizure
- History of brain surgery
- History of recent traumatic brain injury (within 6 months) or any history of moderate to severe traumatic brain injury
- Clinical evidence of severe or uncontrolled alcohol or substance use disorders within three months
- Active withdrawal from alcohol or other substances of abuse
Show all 9Show fewer
- Implanted metal device in the head that would increase the risk of TMS
- Metal in the head that would increase the risk of TMS
- Current psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05001-3833
About this study
Official title: Assessing an Electroencephalography (EEG) Biomarker of Response to Transcranial Magnetic Stimulation for Major Depression
Veterans with treatment resistant depression (TRD) have the opportunity to receive transcranial magnetic stimulation (TMS) treatment via the VA's National TMS Clinical Pilot Program. While some see improvement with their depression, others do not. Therefore, it may be beneficial to be able to predict with biomarkers what participants may see improvement with their treatment. Electroencephalography (EEG) is a means to identify such biomarkers. Four hundred Veterans with TRD will be enrolled in this trial to determine whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation (TMS) can be prospectively replicated in a large ecologically valid sample. Participants will have a total of EEG scans at baseline, every 5th treatment session, and at the end of treatment for a total of 7 EEG scans.
Read the detailed description
The goals of this study are to: (1) test a potential predictive resting EEG biomarker of antidepressant response (differential patters of gamma oscillations) in a large sample of Veterans with TRD receiving TMS (N=400); (2) assess whether a second putative biomarker (early changes in theta cordance during treatment) predict eventual response to TMS, as well as, leverage this large sample to identify other potential biomarkers (such as markers of early versus late response to TMS, markers of response to other TMS parameters (e.g., 5 Hz, 1 Hz or theta burst TMS), and markers of change with treatment that may speak to mechanism); and (3) create an infrastructure to rapidly identify and test additional EEG-based biomarkers of treatment response in patients with depression and other psychiatric conditions.
- Conditions
- Depression
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- depression, transcranial magnetic stimulation, electroencephalography, biomarkers
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationOther
Also called TMS; Repetitive Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation is delivered as part of routine care and is not managed by this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Transcranial Magnetic Stimulation is delivered as part of routine care and is not managed by this observational study. Receives: Other: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR)
The IDS-SR is a 30-item self-report depressive symptom severity rating scale. The IDS-SR has been shown to have highly acceptable psychometric properties and has been found to be a treatment sensitive measures of symptom severity in depression. Each question is on a scale of 0 to 4. The IDS-SR has a score range between 0 to 84, with a higher score reflecting higher symptom severity in depression.
Measured: 1) Baseline, pre-treatment and 2) 6 weeks, treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start19 Aug 2021
- Primary completion30 Sep 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 266 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, Minneapolis Veterans Affairs Medical Center, Providence VA Medical Center, James A. Haley Veterans Administration Hospital, White River Junction Veterans Affairs Medical Center, Emory University, University of California, Los Angeles, Edward Hines Jr. VA Hospital, VA Greater Los Angeles Healthcare System, VA Pittsburgh Healthcare System, San Diego Veterans Healthcare System, Michael E. DeBakey VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Paul Holtzheimer, MD, Principal investigator, White River Junction VA Medical Center, White River Junction, VT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008198
- Sponsor's protocol ID
- CSDR-001-19S
- Status last verified
- Oct 2025
- First submitted
- 30 Jul 2021
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing an Electroencephalography (EEG) Biomarker of Response to Transcranial Magnetic Stimulation for Major Depression
- ClinicalTrials.gov ID
- NCT05008198
- Acronym / sponsor ID
- CSDR-001-19S
- Conditions
- Depression
- Keywords
- depression, transcranial magnetic stimulation, electroencephalography, biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 266 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Palo Alto Health Care System, Minneapolis Veterans Affairs Medical Center, Providence VA Medical Center, James A. Haley Veterans Administration Hospital, White River Junction Veterans Affairs Medical Center, Emory University, University of California, Los Angeles, Edward Hines Jr. VA Hospital, VA Greater Los Angeles Healthcare System, VA Pittsburgh Healthcare System, San Diego Veterans Healthcare System, Michael E. DeBakey VA Medical Center
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Aug 2021 (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.
Veterans with treatment resistant depression (TRD) have the opportunity to receive transcranial magnetic stimulation (TMS) treatment via the VA's National TMS Clinical Pilot Program. While some see improvement with their depression, others do not. Therefore, it may be beneficial to be able to predict with biomarkers what participants may see improvement with their treatment. Electroencephalography (EEG) is a means to identify such biomarkers. Four hundred Veterans with TRD will be enrolled in this trial to determine whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation (TMS) can be prospectively replicated in a large ecologically valid sample. Participants will have a total of EEG scans at baseline, every 5th treatment session, and at the end of treatment for a total of 7 EEG scans.
Detailed description
The goals of this study are to: (1) test a potential predictive resting EEG biomarker of antidepressant response (differential patters of gamma oscillations) in a large sample of Veterans with TRD receiving TMS (N=400); (2) assess whether a second putative biomarker (early changes in theta cordance during treatment) predict eventual response to TMS, as well as, leverage this large sample to identify other potential biomarkers (such as markers of early versus late response to TMS, markers of response to other TMS parameters (e.g., 5 Hz, 1 Hz or theta burst TMS), and markers of change with treatment that may speak to mechanism); and (3) create an infrastructure to rapidly identify and test additional EEG-based biomarkers of treatment response in patients with depression and other psychiatric conditions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | – | Other: Transcranial Magnetic StimulationTranscranial Magnetic Stimulation is delivered as part of routine care and is not managed by this observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with major depressive disorder (MDD) participating in the VA Clinical TMS Pilot Program. Given the complex nature of the Veteran population, the primary diagnosis of MDD may be comorbid with other disorders, including post-traumatic stress disorder (PTSD).
Key inclusion criteria (4 listed)
- Veterans participating in the VA TMS Pilot Program age 18 years or older
- Able to provide written informed consent to participate in the EEG portion of this study and to allow linking such data to data collected as part of the TMS Pilot Program
- Diagnosis of MDD based on DSM-5 criteria and be currently depressed despite prior treatment with at least one adequate antidepressant treatment
- Receiving stable doses of psychiatric medications (no dose changes for >4 weeks prior to study entry), in stable psychotherapy, or receiving no psychiatric medications and/or psychotherapy
Key exclusion criteria (9 listed)
- History of seizure disorder
- Known structural or neurologic abnormalities present or close to the treatment site that would increase risk of seizure
- History of brain surgery
- History of recent traumatic brain injury (within 6 months) or any history of moderate to severe traumatic brain injury
- Clinical evidence of severe or uncontrolled alcohol or substance use disorders within three months
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMS; Repetitive Transcranial Magnetic StimulationTranscranial Magnetic Stimulation is delivered as part of routine care and is not managed by this observational study. | Other | Transcranial Magnetic Stimulation |
Primary outcome
Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR)
Time frame: 1) Baseline, pre-treatment and 2) 6 weeks, treatment completion
The IDS-SR is a 30-item self-report depressive symptom severity rating scale. The IDS-SR has been shown to have highly acceptable psychometric properties and has been found to be a treatment sensitive measures of symptom severity in depression. Each question is on a scale of 0 to 4. The IDS-SR has a score range between 0 to 84, with a higher score reflecting higher symptom severity in depression.
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 22 Oct 2025.
- 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.
Paul Holtzheimer, MD principal investigator
White River Junction VA Medical Center, White River Junction, VT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by VA Office of Research and Development 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2025. 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.
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?
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?
Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR) (time frame: 1) Baseline, pre-treatment and 2) 6 weeks, treatment completion). 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 22 Oct 2025.