The Safety and Efficacy of Nexalin Trans-cranial Electrical Stimulation Stimulation for the Treatment of Depression

Study Overview
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Brief Summary
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The purpose of this research study is to determine whether Nexalin Trans-Cranial Electrical Stimulation (TES) is an effective treatment for depression among patients who are candidates for ECT. A secondary aim to assess whether Nexalin can be used as an alternative to ECT. Although Nexalin has been approved for use in the US, using Nexalin to treat depression in this way is investigational and experimental. If Nexalin is found to be an alternative to ECT, it could offer a safer treatment for depression with less side-effects and a lower cost. !!! NOTE !!! Post Script / Post Study. The ECT arm (profiling subjects as ECT accepters vs. rejecters) was dropped owing to site objections by referring clinicians. Accordingly, the study was framed as a simple comparison between TES and SHAM TES.

Detailed Description
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A 2x2 factor Randomized Controlled Trial with block randomization. Inpatient subjects at the Carrier Clinic who are referred for ECT will be recruited, typed regarding their acceptance of ECT, and randomized to either treatment with TES or to a Sham condition. Treatment non-responders in either condition will continue as in patients at the Carrier Clinic until they reach acceptable levels of functioning to be discharged.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Nexalin Electrical Brain Stimulation for the Treatment of Depression in Patients Referred to Electro-Convulsive Therapy

Conditions
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Depression

Intervention / Treatment
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* Device: Nexalin Based Trans-Cranial Electrical Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In-patients at the Carrier Clinic Adults over age 18 and under age 65 Able to speak, read and write fluently in English, assessed by the study coordinator at Carrier Clinic Screened Negative for alcohol abuse and/or dependence Able to provide informed consent, assessed by the study coordinator at Carrier Clinic Referred for ECT Not currently taking hypnotics or be prescribed hypnotics during the Nexalin trial Not pregnant or intending to become pregnant during the study Committed to completion of the study Exclusion Criteria: Medically or psychiatrically unstable, where the severity of the illness prohibits the subject from engaging in study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 2x2 factor Randomized Controlled Trial with block randomization
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accept ECT - TES<br>Accept ECT where subject is randomized to TES | Device: Nexalin Based Trans-Cranial Electrical Stimulation<br>* The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current.<br>* Other names: TES;|
| Placebo Comparator: Accept ECT - SHAM<br>Accept ECT where subject is randomized to a SHAM condition | Device: Nexalin Based Trans-Cranial Electrical Stimulation<br>* The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current.<br>* Other names: TES;|
| Experimental: Reject ECT - TES<br>Reject ECT where subject is randomized to TES | Device: Nexalin Based Trans-Cranial Electrical Stimulation<br>* The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current.<br>* Other names: TES;|
| Placebo Comparator: Reject ECT - SHAM<br>Reject ECT where subject is randomized to SHAM | Device: Nexalin Based Trans-Cranial Electrical Stimulation<br>* The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current.<br>* Other names: TES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response | Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents not at all and 3 represents nearly every day. The scale ranges from 0-27. We used percent change (from admission to ex-take) as a our metric. | 1-2 weeks |