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
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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