Neuromodulation Device Use in Patients With Major Depressive Disorder

NCT04496505 | Withdrawn

• 1 other identifier: EUF1076
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 (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

Keywords

Depression; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Depression

  Decrease in depressive symptoms as measured by the Hamilton Depression Rating Scale, rated between 0-54, with higher numbers indicated more depression.

  8 weeks

Study Arms (2)

Control Arm

SHAM COMPARATOR

Participants will use a sham device twice per day for 16 minutes per day for 8 weeks. They will be assessed for symptoms of depression at baseline, along with symptoms every two weeks thereafter until the 8 week mark. Participants will also be assessed for anxiety, irritability, future orientation, quality of life, and rumination.

Device: Sham Device

Treatment Arm

EXPERIMENTAL

Participants will use a device twice per day for 16 minutes per day for 8 weeks. They will be assessed for symptoms of depression at baseline, along with symptoms every two weeks thereafter until the 8 week mark. Participants will also be assessed for anxiety, irritability, future orientation, quality of life, and rumination.

Device: Device

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 .

Treatment Arm

Sham Device 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.

Control Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Willingly provides written informed consent prior to the conduct of any study-related procedures.
• \. 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.
• \. 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.
• \. Able to understand, speak and read English sufficient for the completion of study assessments.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Center of Aurora: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Ari Aal, DO

  Medical Center of Aurora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: a. will provide randomized devices and give study staff a list of device ID numbers to assign in order. Study investigators will have no knowledge of which device is a sham device. will keep blinding information on a separate locked external hard drive that investigators will not have access to. Data attached to each device ID will sent to 's analytics team for statistical analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: August 17, 2020
• Primary Completion: September 17, 2020
• Study Completion: September 17, 2020
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share