Imaging to Improve Brain Stimulation

NCT ID: NCT04016402

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-24

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group

All participants enrolled in the study

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Clinical transcranial magnetic stimulation administered as part of usual care for the study population

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Repetitive Transcranial Magnetic Stimulation (rTMS)

Clinical transcranial magnetic stimulation administered as part of usual care for the study population

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

transcranial magnetic stimulation, theta burst transcranial magnetic stimulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Contraindications to MRI (e.g. implanted metal or electronic devices)
* Montreal Cognitive Assessment (MoCA) score \< 26
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Palo Alto Health Care System

FED

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Allyson C Rosen, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Noah S. Philip, MD

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center, Providence, RI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N2864-C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D3152-R-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Using rTMS to Treat Depression
NCT05424224 ACTIVE_NOT_RECRUITING
rTMS for Depression
NCT06484413 COMPLETED