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Neuromodulation Device Use in Patients With Major Depressive Disorder

NCT04496505 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-05-20

No results posted yet for this study

Summary

Study the neuromodulation device in the treatment of Major Depressive Disorder and associated symptoms.

In this study we use the Hamilton Depression Rating Scale (HAM-D), the Quality of Life Scale (QQLS), the Rumination Response Scale (RRS), the Brief Irritability Test (BIT), the Generalized Anxiety Disorder 7 Item Scale (GAD 7), and the Future Orientation Scale (FOS). This study was designed to mirror real life situations, and thus patients are not asked to stop their pharmaceutical treatments.

Primary hypothesis for this study is:

o Daily use of the device will decrease depressive symptoms as measured by HAM-D.

Secondary hypotheses for these study are:

* Daily use of the device will increase quality of life as measured by the QQLS.
* Daily use of the device will decrease rumination as measured by the RRS.
* Daily use of the device will decrease irritability as measured by the BIT.
* Daily use of the device will increase future orientation as measured by the FOS.
* Daily use of the device will decrease anxiety as measured by the GAD-7.

Conditions

  • Clinical Depression

Interventions

DEVICE

Device

is a mask that uses sequences of flashing lights and analogous sounds to trigger a relaxed state in those with intense pain. Pilot studies have so far shown a statistically significantly decrease in pain, anxiety and opiate withdrawal, as well as an increase in heart rate variability. Preliminary data shows a statistically significant decrease in depression symptoms as measured by Patient Health Questionnaire 9 (PHQ-9) scale .

DEVICE

Sham Device

The sham treatment device was designed to copy the look and feel of thetherapy to a degree that it would be indistinguishable from the true treatment. The sham treatment delivers a series of Audio-Visual Stimulation (AVS) in the form of pulses of light (through closed eyelids) and sound, but that offer no therapeutic effect.

Sponsors & Collaborators

  • Medical Center of Aurora

    lead OTHER

Principal Investigators

  • Ari Aal, DO · Medical Center of Aurora

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2020-09-17
Completion
2020-09-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496505 on ClinicalTrials.gov