Use of Alpha-Stim Cranial-electrotherapy Stimulation (CES) in the Treatment of Anxiety

PHASE4CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Anxiety
Interventions
DEVICE

CES treatment using Alpha-Stim technology

Treatment involves the passage of micro current levels of electrical stimulation across the head via electrodes placed bilaterally on the ears. The current used in this device is no stronger than the current that naturally occurs in the human body. Treatment is delivered using a current equal to 0.5 Hz for a period of 60 mins. Treatment will be self-administered on a daily basis 5-7 days per week.The manufacturer of the device, Electro medical Products, Inc. will provide the devices for the study. They will alter the functional devices to deliver treatment at a therapeutic level of \<1 mA. The current cannot be altered by the participant. Participants will be required to log the date, time, and duration of treatment. The logs will be provided by the PI and will be collected weekly. Participants will also be required to complete the Hamilton Anxiety Rating Scale (HAM-A) and the Hamilton Depression Rating Scale 17 (HAM-D17) at baseline and at weeks 1, 3, and 5.

DEVICE

Shame CES Treatment

Treatment will be self-administered on a daily basis 5-7 days per week.The manufacturer of the device, Electro medical Products, Inc. will provide the devices for the study. They will alter the devices so they cannot emit an electrical current. The ability for the device to emit a current cannot be altered by the participant. Participants will be required to log the date, time, and duration of treatment. The logs will be provided by the PI and will be collected weekly. Participants will also be required to complete the Hamilton Anxiety Rating Scale (HAM-A) and the Hamilton Depression Rating Scale 17 (HAM-D17) at baseline and at weeks 1, 3, and 5.

Trial Locations (2)

24502

Liberty Univeristy Student Care and Grad.Assist Office, Lynchburg

Wyndhurst Counseling Center, Lynchburg

All Listed Sponsors
collaborator

Liberty University

OTHER

lead

Wyndhurst Counseling Center

OTHER

NCT01533415 - Use of Alpha-Stim Cranial-electrotherapy Stimulation (CES) in the Treatment of Anxiety | Biotech Hunter | Biotech Hunter