Efficacy of Cranial Electrotherapy Stimulation (CES) for the Treatment of Major Depressive Disorder

NCT03222752 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-04-27

No results posted yet for this study

Summary

Efficacy of Cranial Electrotherapy Stimulation (CES) for the treatment of Major Depressive Disorder

Conditions

Interventions

DEVICE

Cranial Electrotherapy Stimulation

Alpha-Stim® AID microcurrent and cranial electrotherapy stimulator will be used. Daily one hour cranial electrotherapy stimulation (CES) treatment using ear clip electrodes with current set at fixed level of 100 uA (a subsensory current level), 0.5 Hertz will be used for active CES treatment group for 6 weeks. For the sham group the Alpha-Stim® AID ear clips will not emit electricity.

DEVICE

Sham Cranial Electrotherapy Stimulation

The sham treatment will be using a sham Alpha-Stim AID which will look and sound exactly like the active treatment but will deliver no current.

Sponsors & Collaborators

  • Electromedical Products International, Inc.

    lead INDUSTRY

Principal Investigators

  • Timothy Barclay, PhD · Liberty University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2023-04-25
Completion
2023-04-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03222752 on ClinicalTrials.gov