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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-30

Study Completion Date

2031-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depression Repetitive Transcranial Magnetic Stimulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Electroencephalogram (EEG)

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

Electroencephalogram (EEG)

Intervention Type 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.

Interventions

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Electroencephalogram (EEG)

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No