Assessing an EEG Biomarker of Response to TMS for Major Depression

Depression Clinical Trial

Official title:

Assessing an Electroencephalography (EEG) Biomarker of Response to Transcranial Magnetic Stimulation for Major Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008198
• Other study ID #: CSDR-001-19S
• Status: Recruiting
• Start date: August 19, 2021
• Est. completion date: September 30, 2026

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Paul Holtzheimer, MD
• Phone: (802) 295-9363
• Email: Paul.Holtzheimer[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation is delivered as part of routine care and is not managed by this observational study.

Locations

Country	Name	City	State
United States	White River Junction VA Medical Center, White River Junction, VT	White River Junction	Vermont

Sponsors (11)

Lead Sponsor	Collaborator
VA Office of Research and Development	Edward Hines Jr. VA Hospital, Emory University, James A. Haley Veterans' Hospital, Minneapolis Veterans Affairs Medical Center, Pittsburgh VA Medical Center, Providence VA Medical Center, University of California, Los Angeles, VA Greater Los Angeles Healthcare System, VA Palo Alto Health Care System, White River Junction Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1) Baseline, pre-treatment and 2) 6 weeks, treatment completion