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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: Nexalin Based Trans-Cranial Electrical Stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Belle Mead, New Jersey, United States, 08502
      • Carrier Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. In-patients at the Carrier Clinic
2. Adults over age 18 and under age 65
3. Able to speak, read and write fluently in English, assessed by the study coordinator at Carrier Clinic
4. Screened Negative for alcohol abuse and/or dependence
5. Able to provide informed consent, assessed by the study coordinator at Carrier Clinic
6. Referred for ECT
7. Not currently taking hypnotics or be prescribed hypnotics during the Nexalin trial
8. Not pregnant or intending to become pregnant during the study
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accept ECT - TES; Accept ECT where subject is randomized to TES	Device: Nexalin Based Trans-Cranial Electrical Stimulation; 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
Placebo Comparator: Accept ECT - SHAM; Accept ECT where subject is randomized to a SHAM condition	Device: Nexalin Based Trans-Cranial Electrical Stimulation; 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
Experimental: Reject ECT - TES; Reject ECT where subject is randomized to TES	Device: Nexalin Based Trans-Cranial Electrical Stimulation; 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
Placebo Comparator: Reject ECT - SHAM; Reject ECT where subject is randomized to SHAM	Device: Nexalin Based Trans-Cranial Electrical Stimulation; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Carrier Clinic

Publications and helpful links

General Publications

• Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
• Yavari F, Jamil A, Mosayebi Samani M, Vidor LP, Nitsche MA. Basic and functional effects of transcranial Electrical Stimulation (tES)-An introduction. Neurosci Biobehav Rev. 2018 Feb;85:81-92. doi: 10.1016/j.neubiorev.2017.06.015. Epub 2017 Jul 6.
• Bestmann S, Walsh V. Transcranial electrical stimulation. Curr Biol. 2017 Dec 4;27(23):R1258-R1262. doi: 10.1016/j.cub.2017.11.001.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): May 17, 2018
• Study Completion (Actual): May 17, 2018

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: IRB 824349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The de-identified data will be shared with our collaborators at Nexalin and Carrier Clinic.
• IPD Sharing Time Frame: with 6-18 months
• IPD Sharing Access Criteria: Only our direct collaborators.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes