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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Device: Nexalin Based Trans-Cranial Electrical Stimulation

• Registration Number: NCT03277846
• Lead Sponsor: University of Pennsylvania

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.

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 Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-11
• Primary Completion: 2018-05-17
• Study Completion: 2018-05-17
• Results First Submitted: 2019-05-07
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-04
• Last Update Submitted: 2019-10-04
• Results First Posted: 2019-10-28
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

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Exclusion Criteria

Medically or psychiatrically unstable, where the severity of the illness prohibits the subject from engaging in study procedures.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reject ECT - SHAM	Nexalin Based Trans-Cranial Electrical Stimulation	Reject ECT where subject is randomized to SHAM
Accept ECT - TES	Nexalin Based Trans-Cranial Electrical Stimulation	Accept ECT where subject is randomized to TES
Accept ECT - SHAM	Nexalin Based Trans-Cranial Electrical Stimulation	Accept ECT where subject is randomized to a SHAM condition
Reject ECT - TES	Nexalin Based Trans-Cranial Electrical Stimulation	Reject ECT where subject is randomized to TES

Primary Outcome Measures

Name	Time	Method
Treatment Response	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.

Trial Locations

Locations (1)

Carrier Clinic; 🇺🇸 Belle Mead, New Jersey, United States