White River Junction,
Vermont
05009
Purpose:
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.
Study summary:
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.
Criteria:
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
Primary Contact:
Principal Investigator
Paul Holtzheimer, MD
White River Junction VA Medical Center, White River Junction, VT
Paul Holtzheimer, MD
Phone: (802) 295-9363 ext. 6042
Email: Paul.Holtzheimer@va.gov