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

NCT04575285 | Withdrawn

• 1 other identifier: TMS Depression
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Repetitive Transcranial Magnetic Stimulation

Keywords

rTMS

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale score

  Hamilton Depression Rating Scale is used to measure severity of depression on a scale from 0 (no depression) to 52 (most severe depression).

  baseline, and weekly until study completion, which can be up to 6 weeks

Secondary Outcomes (1)

• Electroencephalograph (EEG) scalp signal changes over time

  baseline, end of treatment, which can be up to 6 weeks

Study Arms (1)

Electroencephalogram (EEG)

All participants will undergo EEG recording at baseline and end of treatment for a duration of 10-20 minutes per session.

Diagnostic Test: Electroencephalogram (EEG)

Interventions

Electroencephalogram (EEG) DIAGNOSTIC_TEST

EEG measures brain activity by recording the spontaneous brain electrical activity and evoked responses non-invasively from the scalp. Reusable Tangle Free 10mm EEG Cup Electrodes will be placed on the subject's scalp using the 10-20 system montage.

Electroencephalogram (EEG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will be treated for major depression using rTMS (according to standard care)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baptist Health South Florida: lead
• Florida International University: collaborator

Study Sites (1)

Starlie C Belnap

Miami, Florida, 33176, United States

Location

Related Links

• Miami Neuroscience Institute

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Geetha Nampiaparampil, MD

  Miami Cancer Institute (MCI) at Baptist Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 5, 2020
• Study Start: April 1, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: June 25, 2024

Record last verified: 2022-03

Locations

US (1)