Trial Outcomes & Findings for Cranial Electrotherapy Stimulation (CES) Therapy (NCT NCT02453347)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Four Weeks

Results posted on

2018-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	CES Therapy 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. CES Therapy: 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.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
Age, Categorical <=18 years	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants
Age, Continuous	38.5 years STANDARD_DEVIATION 8.57 • n=6 Participants
Sex: Female, Male Female	0 Participants n=6 Participants
Sex: Female, Male Male	6 Participants n=6 Participants
Region of Enrollment United States	6 participants n=6 Participants

PRIMARY outcome

Timeframe: Four Weeks

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.

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
PCL-5 (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders) for Use in Treating PTSD Symptoms	44.25 scores on a scale Standard Deviation 17.87

PRIMARY outcome

Timeframe: Four Weeks

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.

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
State-Trait Anxiety Inventory (STAI)	81.375 scores on a scale Standard Deviation 16.85

PRIMARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
Beck Depression Inventory (BDI)	25 score Standard Deviation 13.9

PRIMARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
TFI (Tinnitus Functional Index)	94.875 scores on a scale Standard Deviation 45.26

PRIMARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
MPAI (Mayo Portland Adaptability Inventory)	48 scores on a scale Standard Deviation 16.34

PRIMARY outcome

Timeframe: 4 weeks

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).

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
WAIS (Wechsler Adult Intelligence Scale) Symbol Search	26.75 scores on a scale Standard Deviation 10.41

PRIMARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
WAIS Coding - Wechsler Adult Intelligence Scale	55.5 scores on a scale Standard Deviation 23.9

SECONDARY outcome

Timeframe: Four Weeks

To measure the effect of CES use on somatic symptoms related to TBI (Traumatic Brain Injury), including dizziness. The assessment scale rate 22 symptoms that may have disturbed subjects from 0 = no symptoms to 4 = very severe in the previous 2 weeks. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater the symptoms.

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
Dizziness- NSI (Neurobehavioral Symptom Inventory)	40.8 scores on a scale Standard Deviation 21.5

SECONDARY outcome

Timeframe: Four Weeks

To assess for improvements in measures of somatic symptoms related to TBI (headaches). The test is scored by adding points to 6 different categories related to frequency and severity of symptoms. The 6 category scores are summed to yield a total score ranging from 36 to 78. Fewer points signify less severity and higher point scores signify more severe symptoms according to patient assessment.

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
Headache - HIT6 (Headache Impact Test)	62.37 scores on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Four Weeks

To assess for improvements in measures of somatic symptoms related to TBI (insomnia). The scoring consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Outcome measures

Outcome measures
Measure	CES Therapy n=6 Participants 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. CES Therapy: 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.
Sleep - Pittsburgh Sleep Quality Index (PSQI)	10.5 scores on a scale Standard Deviation 5.26

Adverse Events

CES Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carlos Jaramillo

Audie L. Murphy Veterans Administration Hospital

Phone: 210-617-5300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place