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

NCT03277846 | Completed Results DMC FDA Device

• 1 other identifier: IRB 824349
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Accept ECT - TES

EXPERIMENTAL

Accept ECT where subject is randomized to TES

Device: Nexalin Based Trans-Cranial Electrical Stimulation

Accept ECT - SHAM

PLACEBO COMPARATOR

Accept ECT where subject is randomized to a SHAM condition

Device: Nexalin Based Trans-Cranial Electrical Stimulation

Reject ECT - TES

EXPERIMENTAL

Reject ECT where subject is randomized to TES

Device: Nexalin Based Trans-Cranial Electrical Stimulation

Reject ECT - SHAM

PLACEBO COMPARATOR

Reject ECT where subject is randomized to SHAM

Device: Nexalin Based Trans-Cranial Electrical Stimulation

Interventions

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.

Also known as: TES

Accept ECT - SHAM; Accept ECT - TES; Reject ECT - SHAM; Reject ECT - TES

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Carrier Clinic: collaborator

Study Sites (1)

Carrier Clinic

Belle Mead, New Jersey, 08502, United States

Location

Related Publications (3)

• Bestmann S, Walsh V. Transcranial electrical stimulation. Curr Biol. 2017 Dec 4;27(23):R1258-R1262. doi: 10.1016/j.cub.2017.11.001.

  PMID: 29207262 BACKGROUND

• 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.

  PMID: 28709880 BACKGROUND

• 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.

  PMID: 28688701 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Michael Perlis
• Organization: University of Pennsylvania

mperlis@upenn.edu

215-746-3577

Study Officials

• Michael L Perlis, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants and investigators are blind to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 2x2 factor Randomized Controlled Trial with block randomization

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 11, 2017
• Study Start: September 1, 2017
• Primary Completion: May 17, 2018
• Study Completion: May 17, 2018
• Last Updated: October 28, 2019
• Results First Posted: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: with 6-18 months
• Access Criteria: Only our direct collaborators.

Locations

US (1)