Major Depressive DisorderNCT02843373
Brain-Based Biomarkers in Response to TMS in MDD
An observational study of Major Depressive Disorder and Depression, run by Stanford University at 1 site in United States.
Trial summary
The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder, Depression
- What is being tested?
- TMS
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Community care clinic
Who may be able to join
- Men and women, ages 18 to 60
- Medication-resistant depression as assessed by psychiatrist
- Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
- Has failed >1 previous adequate antidepressant medication trials
- Right-handed
- No current or history of neurological disorders
- No seizure disorder or risk of seizures
- No use of PRN medication within 48 hours of the scheduled study appointment
Who cannot join
- Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
- Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
- Currently pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal, Prospective Study to Examine the Brain-based Biomarkers of Response to Transcranial Magnetic Stimulation Treatment in Major Depressive Disorder
The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the investigators can overcome a major limitation of EEG - the inability to demonstrate causality. Here, we plan to recruit patients with medication-resistant depression undergoing rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the excitability and connectivity profiles of brain networks and how they are modulated during treatment. This study aims to provide objective brain network measures that can predict and track clinical response to TMS treatment. Findings from this study will be utilized to develop a novel, personalized treatment protocol based on individual brain networks.
Read the detailed description
Goals of the study are as follows:
- To evaluate the ability to predict and track brain network changes during TMS treatment for medication-resistant depression.
- To develop quantitative tools that measure the connectivity and excitability of the brain using resting and single pulse TMS-EEG.
- To determine the feasibility of recording EEG biomarkers in the clinic without disrupting clinical care.
- Conditions
- Major Depressive Disorder, Depression
- Being tested
- TMS
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
| Study group | Role | What they receive |
|---|---|---|
| rTMS | rTMS will be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS will be delivered to the left DLPFC as assessed by either the 5cm rule or F3 site. Daily treatment regiments will last 36.5 minutes and rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS sessions for adverse events and/or side effects. Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMS-EEG
From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corey Keller, Stanford University
- Investigators
- Corey Keller, MD PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843373
- Sponsor's protocol ID
- IRB-25948
- Status last verified
- Jun 2022
- First submitted
- 20 Jul 2016
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal, Prospective Study to Examine the Brain-based Biomarkers of Response to Transcranial Magnetic Stimulation Treatment in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02843373
- Acronym / sponsor ID
- IRB-25948
- Conditions
- Major Depressive Disorder, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Jul 2016 (estimated)
- 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.
The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the investigators can overcome a major limitation of EEG - the inability to demonstrate causality. Here, we plan to recruit patients with medication-resistant depression undergoing rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the excitability and connectivity profiles of brain networks and how they are modulated during treatment. This study aims to provide objective brain network measures that can predict and track clinical response to TMS treatment. Findings from this study will be utilized to develop a novel, personalized treatment protocol based on individual brain networks.
Detailed description
Goals of the study are as follows:
- To evaluate the ability to predict and track brain network changes during TMS treatment for medication-resistant depression.
- To develop quantitative tools that measure the connectivity and excitability of the brain using resting and single pulse TMS-EEG.
- To determine the feasibility of recording EEG biomarkers in the clinic without disrupting clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS | – | Device: TMSrTMS will be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS will be delivered to the left DLPFC as assessed by either the 5cm rule or F3 site. Daily treatment regiments will last 36.5 minutes and rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS sessions for adverse events and/or side effects. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Community care clinic
Key inclusion criteria (8 listed)
- Men and women, ages 18 to 60
- Medication-resistant depression as assessed by psychiatrist
- Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
- Has failed >1 previous adequate antidepressant medication trials
- Right-handed
Key exclusion criteria (3 listed)
- Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
- Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
- Currently pregnant or breastfeeding
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 |
|---|---|---|
| TMS | Device | rTMS |
Primary outcome
TMS-EEG
Time frame: Up to 3 months
From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity
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 23 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
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.
Corey Keller, MD PhD principal investigator
Stanford University
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 Major Depressive Disorder and Depression, run by Stanford University 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 8 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 23 Jun 2022. 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?
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?
TMS-EEG (time frame: Up to 3 months). 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 23 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.