Cranial Electrotherapy Stimulation (CES) Therapy

NCT02453347 | Completed Results

• 1 other identifier: 15-352H (UTHSCSA IRB)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this proposed study is to gather preliminary data for CES use in treating PTSD and anxiety symptoms in OEF/OIF Veterans with PTSD and a history of TBI.

Conditions

TBI; Anxiety; PTSD; Depression

Keywords

Stable chronic medical conditions; No current alcohol or substance abuse; Alpha Stim

Outcome Measures

Primary Outcomes (7)

• PCL-5 (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders) for Use in Treating PTSD Symptoms

  To measure the effect of Cranial Electrotherapy Stimulation (CES) use on symptoms related to PTSD. The PCL-5 is a self-report measure that can be completed by patients in a waiting room prior to a session or by participants as part of a research study. The survey has 20 questions scored as: 0=Not at all 1. A little bit 2. Moderately 3. Quite a bit 4. Extremely Interpretation of the PCL-5 should be made by a clinician. The total symptom severity score is obtained by summing the scores for each of the 20 items and ranges from 0 to 80. The lower the score, the less severe the symptoms of PTSD, the higher the score, the more severe the symptoms. For a person to have a probable diagnosis of PTSD sufficient criteria must be moderately to extremely met in each of the four symptom groups (i.e., one or more of questions 1-5, either question 6 or 7, two or more of questions 8-14, two or more of questions 15-20). In addition, a score of 38 or higher indicates probable PTSD in veterans.

  Four Weeks

• State-Trait Anxiety Inventory (STAI)

  To measure the effect of CES use on trait and state anxiety. These scales comprise 20 items each and are scored on 4-point forced-choice response scales from 1 (seldom) to 4 (frequent). Scores range from 20 to 80, with higher scores suggesting greater levels of anxiety.The state and trait anxiety scales both range from 20 to 80 and are combined to yield a total score ranging from 40 to 160, where low scores suggest mild anxiety, median scores suggest moderate anxiety, and high scores suggest severe anxiety. Both scales include direct (presence of anxiety) and reverse-worded (absence of anxiety) items. Reverse-worded item scores are reverse scored and then totaled with the remaining items.

  Four Weeks

• Beck Depression Inventory (BDI)

  A 21 question set to assess subjects feelings in the last week. Each question has a set of at least 4 possible responses, ranging in intensity: (0) I do not feel sad. 1. I feel sad. 2. I am sad all the time and I can't snap out of it. 3. I am so sad or unhappy that I can't stand it. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score ranging from 0 to 63 is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms.

  4 weeks

• TFI (Tinnitus Functional Index)

  To measure the severity of tinnitus. The survey consists of 25 questions ranked from 0 (did not interfere) to 10 (completely interfered). At least 19 of the 25 questions are required to be answered, and rankings are added together to give a maximum possible score of 250, which would be the most severe interference by tinnitus.

  4 weeks

• MPAI (Mayo Portland Adaptability Inventory)

  The inventory consists of 29 items in 3 subscales (Ability, the Adjustment and Participation Index) plus an additional 6 items that are not included in the MPAI-4 score. The first 29 scale items are intended to reflect the current status of the individual with brain injury without attempting to determine whether their status might be influenced by factors other than ABI (acquired brain injury). Items are scored from 0 to 4, with 0 being the most favorable score for each item, with a cumulative score ranging from 0 to 116 for all the items. A lower score indicates better adaptability.

  4 weeks

• WAIS (Wechsler Adult Intelligence Scale) Symbol Search

  The Symbol Search subtest of the Wechsler Adult Intelligence scale designed to assess information processing speed and visual perception with a minimum score of 0 as the lowest (worst performance) to 60 as the highest score (best performance).

  4 weeks

• WAIS Coding - Wechsler Adult Intelligence Scale

  The test has two batteries of subtests grouped into two general areas: 1) Verbal scales; and 2) Performance scales. The Verbal scales measure general knowledge, language, reasoning, and memory skills, while the Performance scales measure spatial, sequencing, and problem-solving skills. The tests are administered to individual examinees by trained examiners, using a complex set of test materials. Testing requires approximately 90 minutes. Raw scores on each test are converted to standard scores with a mean of 10 and a standard deviation of 3. Scale scores in the Verbal battery are summed and converted to a Verbal Intelligence Quotient (IQ) score; the same is done for the Performance scale scores which yield the Performance IQ score. In turn, the Verbal and Performance IQ scores are summed and converted to obtain the Full Scale (overall) IQ score with a mean of 100 and a standard deviation of 15. Higher scores indicate a higher IQ.

  4 weeks

Secondary Outcomes (3)

• Dizziness- NSI (Neurobehavioral Symptom Inventory)

  Four Weeks

• Headache - HIT6 (Headache Impact Test)

  Four Weeks

• Sleep - Pittsburgh Sleep Quality Index (PSQI)

  Four Weeks

Study Arms (1)

CES Therapy

EXPERIMENTAL

All participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later.

Device: CES Therapy

Interventions

CES Therapy DEVICE

Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain.

Also known as: Cranial Electrotherapy Stimulation (CES) Therapy, Alpha Stim

CES Therapy

Eligibility Criteria

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

You may qualify if:

• Male outpatient, OEF/OIF/OND Veterans diagnosed during the course of clinical care with mild TBI and PTSD, and screened positive for anxiety
• Good medical health and stable chronic medical conditions.
• No current alcohol or substance abuse.

You may not qualify if:

• Patients with moderate or severe TBI or seizure disorders.
• Prior CES use
• Diagnosis of Bipolar Disorder, Schizophrenia, or other psychiatric condition that would require inpatient hospitalization or medical disease that would impair reliable participation in the trial.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Audie L. Murphy VA Hospital

San Antonio, Texas, 78230, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Depression; Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Carlos Jaramillo
• Organization: Audie L. Murphy Veterans Administration Hospital

jaramilloc3@uthscsa.edu

210-617-5300

Study Officials

• Carlos A Jaramillo, M.D., Ph.D.

  San Antonio Polytrauma Center South Texas Veterans Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 25, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 28, 2018
• Results First Posted: February 28, 2018

Record last verified: 2017-11

Locations

US (1)