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

Major Depression Clinical Trial

Official title:

Using EEG to Predict Depression Treatment Response to Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Major Depression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04575285
• Other study ID #: TMS Depression
• Status: Withdrawn
• Start date: April 2020
• Est. completion date: December 1, 2031

Study information

• Verified date: March 2022
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2031
• Est. primary completion date: December 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Repetitive Transcranial Magnetic Stimulation

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Starlie C Belnap	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Baptist Health South Florida	Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Electroencephalograph (EEG) scalp signal changes over time	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).	baseline, end of treatment, which can be up to 6 weeks

External Links

•   Miami Neuroscience Institute