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

NCT01533415 | Completed Phase 4

• 1 other identifier: 1241.020712
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Anxiety

Keywords

Anxiety; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• Anxiety symptoms as reported on the Hamilton Anxiety Rating Scale

  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.

  Change from Baseline in Hamilton Anxiety Rating Scale scores assessed at different points, e.g., Week 1, Week 3, and Week 5.

• Depression symptoms as reported on the Hamilton Depression Rating Scale 17

  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.

  Change from Baseline in Hamilton Depression Rating Scale 17 scores assessed at different points, e.g., Week 1, Week 3, and Week 5.

Study Arms (2)

Active CES treatment

ACTIVE COMPARATOR

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

Sham CES treatment

SHAM COMPARATOR

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

Interventions

CES treatment using Alpha-Stim technology DEVICE

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.

Also known as: Alpha-Stim, CES, Anxiety

Active CES treatment

Shame CES Treatment DEVICE

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.

Also known as: Alpha-Stim, CES, Anxiety

Sham CES treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyndhurst Counseling Center: lead
• Liberty University: collaborator

Study Sites (2)

Liberty Univeristy Student Care and Grad.Assist Office

Lynchburg, Virginia, 24502, United States

Location

Wyndhurst Counseling Center

Lynchburg, Virginia, 24502, United States

Location

Related Publications (2)

• Klawansky S, Yeung A, Berkey C, Shah N, Phan H, Chalmers TC. Meta-analysis of randomized controlled trials of cranial electrostimulation. Efficacy in treating selected psychological and physiological conditions. J Nerv Ment Dis. 1995 Jul;183(7):478-84. doi: 10.1097/00005053-199507000-00010.

  PMID: 7623022 BACKGROUND

• Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. 2014 Aug;164:171-7. doi: 10.1016/j.jad.2014.04.029. Epub 2014 Apr 21.

  PMID: 24856571 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tim H Barclay, Ph.D.

  Liberty University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor

Study Record Dates

• First Submitted: February 11, 2012
• First Posted: February 15, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

US (2)