Using EEG to Predict Depression Treatment Response to rTMS in Patients With Major Depression

Withdrawn

• Conditions: Repetitive Transcranial Magnetic Stimulation; Major Depression
• Interventions: Diagnostic Test: Electroencephalogram (EEG)

• Registration Number: NCT04575285
• Lead Sponsor: Baptist Health South Florida

Brief Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. The study is looking at changes in specific electroencephalogram parameters in depressed patients treated with rTMS can serve as predictors of depression treatment response among cancer patents undergoing rTMS treatment of depression.

Detailed Description

The study will be a prospective, single arm trial in which a set of patients who will be treated for major depression using Repetitive Transcranial Magnetic Stimulation (according to FDA approved rTMS standard care practices) also will undergo EEG recording before Repetitive Transcranial Magnetic Stimulation treatment begins, and at the completion of treatment. The Hamilton Depression Rating Scale will be given to participants by the neuropsychiatrist at baseline and weekly intervals till the completion of treatment.

The neuropsychiatrist investigators expect to see about 12 patients per year who meet treatment criteria for Repetitive Transcranial Magnetic Stimulation. Therefore, it is expected to recruit 24 subjects into the research study over a two-year period.

Study Timeline

• Study Start: 2020-04
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Status Verified: 2022-03
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2030-12-01
• Study Completion: 2031-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosed with cancer
• Comorbid diagnosis of major depressive disorder
• Age ≥ 18 years
• Baseline Hamilton Depression Rating Scale (HDRS) score ≥ 18
• Failed one or more adequate antidepressant trials (including selective serotonin reuptake inhibitors or SSRIs, selective norepinephrine reuptake inhibitors or SNRIs, tricyclic antidepressants or TCAs). A failed treatment response may be due to lack of antidepressant efficacy or intolerable side effects.

Exclusion Criteria

• History of seizure or epilepsy
• History of concussion
• History of bipolar disorder
• Comorbid psychotic disorder
• Primary brain tumor or metastasis to brain
• Active comorbid substance use disorder
• History or current diagnosis of dementia
• Current pregnancy
• Unable to attend regular treatment sessions
• Any other condition in which a physician investigator feels may subject the participant to undue risk

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electroencephalogram (EEG)	Electroencephalogram (EEG)	All participants will undergo EEG recording at baseline and end of treatment for a duration of 10-20 minutes per session.

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale score	baseline, and weekly until study completion, which can be up to 6 weeks	Hamilton Depression Rating Scale is used to measure severity of depression on a scale from 0 (no depression) to 52 (most severe depression).

Secondary Outcome Measures

Name	Time	Method
Electroencephalograph (EEG) scalp signal changes over time	baseline, end of treatment, which can be up to 6 weeks	Change in brain activity as measured by the EEG in microvolts.Scalp EEG signals will be processed in order to compare EEG brain connectivity and Frontal alpha asymmetry index (FAA).

Trial Locations

Locations (1)

Starlie C Belnap; 🇺🇸 Miami, Florida, United States