N/A N=101 Randomized Quadruple-blind Treatment

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

Depression

Bottom Line

View on ClinicalTrials.gov: NCT03277846 ↗

Enrolled (actual)

101

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Treatment Response — 28; 29 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nexalin Based Trans-Cranial Electrical Stimulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Response	28; 29	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03277846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.