Status:
WITHDRAWN
Neuromodulation Device Use in Patients With Major Depressive Disorder
Lead Sponsor:
Medical Center of Aurora
Conditions:
Clinical Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 (Q...
Detailed Description
Experimental design 1. This study will be a randomized clinical trial to assess the effects of the device on depression as well as ancillary symptoms of depression. The study will involve 2 phases: Sc...
Eligibility Criteria
Inclusion
- 1\. Willingly provides written informed consent prior to the conduct of any study-related procedures.
- 2\. Male or female, 18 to 65 years of age, inclusive. 3. Clinical diagnosis of Major Depressive Disorder. 4. Patient must be in generally good health based upon the results of a medical history, physical examination, and vital signs, at the investigator's discretion.
- 5\. Willing and able to comply with the study requirements, complete study assessments, and visit the clinic at the scheduled times for the duration of the Treatment Phase.
- 6\. Able to understand, speak and read English sufficient for the completion of study assessments.
Exclusion
- Pregnant (verbal patient report only) or lactating.
- History or presence of photo-sensitive epilepsy or other photo-sensitive conditions.
- History or presence of condition(s) that may affect balance, such as seizure disorders or vertigo
- History or presence of migraine, at the investigator's discretion
- Vision impairments that affect perception of light, color, or brightness in one or both eyes, or differences in visual perception between eyes.
- Deafness in one or both ears, perceived differences in hearing between ears or tinnitus.
- Current ear or eye infection, untreated allergies, or acute illness that may affect eyes or hearing (e.g., due to congestion).
- Presence of inflammation or broken skin around the eyes in the area of the mask.
- Participating in any other clinical study in which medication(s) are being delivered or have used an investigational drug or device within the last 30 days.
- Any pending legal action that could prohibit participation or compliance in the study.
- Any psychiatric diagnosis that would preclude competency to consent to participation.
- Significant medical conditions or other circumstances which, in the opinion of the investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the patient from safely participating in study.
- Employee of the investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the investigator or study site, or a family member of an employee or of the investigator.
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04496505
Start Date
August 17 2020
End Date
September 17 2020
Last Update
May 20 2021
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