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

This study has been completed.
Sponsor:
Collaborator:
Liberty University
Information provided by (Responsible Party):
Tim Barclay, Wyndhurst Counseling Center
ClinicalTrials.gov Identifier:
NCT01533415
First received: February 11, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

Is CES effective in the treatment of anxiety when accounting for any comorbid conditions and or current treatments including medication and psychotherapy.


Condition Intervention Phase
Anxiety
 Device: CES treatment using Alpha-Stim technology
Device: Shame CES Treatment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Cranial-electrotherapy Stimulation (CES) Using Alpha-Stim Technology in The Treatment of Anxiety Disorders

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

Further study details as provided by Wyndhurst Counseling Center:

Primary Outcome Measures:
  • Anxiety symptoms as reported on the Hamilton Anxiety Rating Scale [ Time Frame: Change from Baseline in Hamilton Anxiety Rating Scale scores assessed at different points, e.g., Week 1, Week 3, and Week 5. ] [ Designated as safety issue: No ]
    The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scores range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  • Depression symptoms as reported on the Hamilton Depression Rating Scale 17 [ Time Frame: Change from Baseline in Hamilton Depression Rating Scale 17 scores assessed at different points, e.g., Week 1, Week 3, and Week 5. ] [ Designated as safety issue: No ]
    The Hamilton Depression Scale is a test measuring the severity of depressive symptoms in individuals. It is often used as an outcome measure of depression in research. In the 17-item version, nine of the items are scored on a five-point scale, ranging from zero to four. The remaining eight items are scored on a three-point scale. For the 17-item version, scores can range from 0 to 54. 0 and 6 indicate a normal person with regard to depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression.


Enrollment: 115
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active CES treatment
Out of the total population of 150 participants,75 of them will be assigned to the active treatment group. Because this is a double-blind study it is unknown which members will belong to this group until completion of the study.
 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.
Other Names:
  • Alpha-Stim
  • CES
  • Anxiety
Sham Comparator: Sham CES treatment
Of the 150 participants in this study, half of them will be assigned to the sham treatment group. Because this is a double-blind study, it is unknown which members will be assigned to this group until the completion of the study.
 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.
Other Names:
  • Alpha-Stim
  • CES
  • Anxiety

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is male or female outpatients age 18 to 65 years.
  • The subject meets DSM-IV criteria for an anxiety disorder.
  • Participants with comorbidity must carry an anxiety disorder as a primary diagnosis.
  • Written informed consent must be obtained from the subject prior to study participation.
  • The subject is in good medical health or with chronic medical conditions which are currently stable.
  • No current abuse of alcohol or other substance.
  • The subject has a total score greater than 15 on the Beck Anxiety Inventory and a score greater than 45 on the Zung Self Report Anxiety Scale.

Exclusion Criteria:

  • The subject meets DSM-IV criteria for an Axis I diagnosis (other than an Anxiety Disorder) as the primary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa).
  • The subject is clinically judged by the investigator to be at risk for suicide or is acutely suicidal.
  • The subject is clinically judged by the investigator to be at risk for homicide or is acutely homicidal.
  • The subject has a psychiatric condition that would require inpatient, or partial psychiatric hospitalization.
  • Seizure disorders.
  • Significant history of medical disease (i.e. cardiovascular, hepatic (e.g. cirrhosis, hepatitis B or C) renal, gynecological, musculoskeletal, neurological, gastrointestinal, metabolic, hematological, endocrine, cancer with a metastatic potential or progressive neurological disorders) which could impair reliable participation in the trial or necessitate the use of medication not allowed by this protocol.
  • Use of a pacemaker.
  • The subject is pregnant, planning to become pregnant, or nursing. If a subject becomes pregnant, she will be discontinued immediately and followed appropriately.
  • Current psychotherapeutic treatment except for treatment with Specific Reuptake Inhibitor (SSRIs) medications which include: Fluoxetine (Prozac), Paroxetine (Paxil), Sertraline (Zoloft), Luvox (Fluvoxamine), Citalopram. Potential subjects may remain on their medications provided that he or she has been on a stable dose prior to entering this study; the dose and type of medication remains stable throughout the remainder of this study; and it can be determined that this medication is not exacerbating the anxiety symptoms.
  • History of poor compliance or in the Investigator's judgment patients any subject whose treatment as an outpatient would be clinically contraindicated
  • The subject has attempted suicide one or more times within the past twelve months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533415

Locations
United States, Virginia
Wyndhurst Counseling Center
Lynchburg, Virginia, United States, 24502
Liberty Univeristy Student Care and Grad.Assist Office
Lynchburg, Virginia, United States, 24502
Sponsors and Collaborators
Wyndhurst Counseling Center
Liberty University
Investigators
Principal Investigator: Tim H Barclay, Ph.D. Liberty University
  More Information

Publications:

Responsible Party: Tim Barclay, Asst. Professor, Wyndhurst Counseling Center
ClinicalTrials.gov Identifier: NCT01533415     History of Changes
Other Study ID Numbers: 1241.020712
Study First Received: February 11, 2012
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyndhurst Counseling Center:
Anxiety
Anxiety Disorders

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013