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

University of Pennsylvania

Status: Completed

Conditions: Depression

Treatments: Device: Nexalin Based Trans-Cranial Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03277846

IRB 824349

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 4 patient groups, including a placebo group

Accept ECT - TES

Experimental group

Description:

Accept ECT where subject is randomized to TES

Treatment:

Device: Nexalin Based Trans-Cranial Electrical Stimulation

Accept ECT - SHAM

Placebo Comparator group

Description:

Accept ECT where subject is randomized to a SHAM condition

Treatment:

Device: Nexalin Based Trans-Cranial Electrical Stimulation

Reject ECT - TES

Experimental group

Description:

Reject ECT where subject is randomized to TES

Treatment:

Device: Nexalin Based Trans-Cranial Electrical Stimulation

Reject ECT - SHAM

Placebo Comparator group

Description:

Reject ECT where subject is randomized to SHAM

Treatment:

Device: Nexalin Based Trans-Cranial Electrical Stimulation