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Completed

NCT Number: NCT03277846

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carrier Clinic

Belle Mead, New Jersey, 08502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nexalin Based Trans-Cranial Electrical Stimulation

Device

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.

Other names: TES

Primary outcomes

  1. Treatment Response

    Time frame: 1-2 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Carrier Clinic

Registry information

Official study title

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

Acronym: TES

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2017
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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