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

Sponsor
Baptist Health South Florida (Other)
Overall Status
Suspended
CT.gov ID
NCT04575285
Collaborator
Florida International University (Other)
24
Enrollment
1
Location
1
Arm
108
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Electroencephalogram (EEG)
N/A

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 standard care) 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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Using EEG to Predict Depression Treatment Response to Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Major Depression
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2030
Anticipated Study Completion Date :
Dec 1, 2031

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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)
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Miami Neuroscience InstituteMiamiFloridaUnited States33176

Sponsors and Collaborators

  • Baptist Health South Florida
  • Florida International University

Investigators

  • Principal Investigator: Geetha Nampiaparampil, MD, Miami Cancer Institute (MCI) at Baptist Health, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Baptist Health South Florida
ClinicalTrials.gov Identifier:
NCT04575285
Other Study ID Numbers:
  • TMS Depression
First Posted:
Oct 5, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Baptist Health South Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022