Assessing an EEG Biomarker of Response to TMS for Major Depression

VA Office of Research and Development

Status

Enrolling

Conditions

Depression

Treatments

Other: Transcranial Magnetic Stimulation

Study type

Observational

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT05008198

CSDR-001-19S

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
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