TBICESNCT02453347
Cranial Electrotherapy Stimulation (CES) Therapy
A study testing CES Therapy in people with TBI and Anxiety, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- CES Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Audie L. Murphy VA Hospital
San Antonio, Texas, 78230
About this study
Official title: Cranial Electrotherapy Stimulation (CES) Therapy for PTSD and Anxiety in OEF/OIF Veterans With Mild TBI
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.
Read the detailed description
Veterans from conflicts in Afghanistan and Iraq exhibit numerous signature injuries to include posttraumatic stress disorder (PTSD), traumatic brain injury (TBI), and anxiety. These three conditions commonly co-occur together, which presents treatment challenges. First, current treatment guidelines focus on treating each of these conditions individually and do not sufficiently account for comorbid presentation. As a consequence, Veterans with comorbid disorders may have poor clinical health outcomes despite receiving treatment. Second, treating anxiety among Veterans with comorbid PTSD and TBI involves medications that may have limited efficacy (e.g., PTSD medications) or side effects (e.g., drug interactions or diminished cognitive function).
Given these treatment challenges, Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. Briefly, CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain. Additionally, both the Department of Defense (DoD) and Veterans Health Affairs (VHA) prescribe CES to treat trauma-related conditions. CES treatment involves transcutaneous application of pulsed micro-currents of <1000 μA to the patient's head and these currents are tailored specifically for each patient. The studies that have examined efficacy for CES therapy in treating anxiety have shown some positive effects, however, the patient populations were typically small, sometimes limited to case reports, and outcome measures varied significantly. A meta-analysis performed on CES studies over two decades ago found evidence for CES treatment over sham groups, but most of the studies reviewed were missing data and study personnel were not always blinded to the groups. Additionally, CES has showed a significant improvement in anxiety symptoms after of CES therapy in 12 adult patients diagnosed with generalized anxiety disorder (GAD; Bystritsky et al., [2008]). The success of CES in treating anxiety may indicate a suitable signal for exploring its use in PTSD samples (Novakovic et al. [2011]). Given the relatively few CES studies available in the scholarly literature, a 2009 Cochrane Systematic Review found insufficient evidence to support using CES to manage persistent TBI symptoms. While some of these studies are encouraging, the device has not been clearly demonstrated to be effective in the multi-morbid OEF/OIF/OND Veteran population. Additionally, little information is known about the mechanism of action for CES.
- Conditions
- TBI, Anxiety, PTSD, Depression
- Being tested
- CES Therapy
- Keywords
- Stable chronic medical conditions, No current alcohol or substance abuse, Alpha Stim
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CES TherapyDevice
Also called Cranial Electrotherapy Stimulation (CES) Therapy, Alpha Stim
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CES Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- A little bit
- Moderately
- Quite a bit
- 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.
Measured: 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.
Measured: 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.
- I feel sad.
- I am sad all the time and I can't snap out of it.
- 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 4 weeks
Secondary outcomes (3)
Dizziness- NSI (Neurobehavioral Symptom Inventory)
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.
Measured: Four Weeks
Headache - HIT6 (Headache Impact Test)
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.
Measured: Four Weeks
Sleep - Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TBIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos A Jaramillo, M.D., Ph.D., Principal investigator, San Antonio Polytrauma Center South Texas Veterans Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453347
- Sponsor's protocol ID
- 15-352H (UTHSCSA IRB)
- Acronym
- CES
- Status last verified
- Nov 2017
- First submitted
- 14 May 2015
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Electrotherapy Stimulation (CES) Therapy for PTSD and Anxiety in OEF/OIF Veterans With Mild TBI
- ClinicalTrials.gov ID
- NCT02453347
- Acronym / sponsor ID
- CES / 15-352H (UTHSCSA IRB)
- Conditions
- TBI, Anxiety, PTSD, Depression
- Keywords
- Stable chronic medical conditions, No current alcohol or substance abuse, Alpha Stim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Posted 28 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Veterans from conflicts in Afghanistan and Iraq exhibit numerous signature injuries to include posttraumatic stress disorder (PTSD), traumatic brain injury (TBI), and anxiety. These three conditions commonly co-occur together, which presents treatment challenges. First, current treatment guidelines focus on treating each of these conditions individually and do not sufficiently account for comorbid presentation. As a consequence, Veterans with comorbid disorders may have poor clinical health outcomes despite receiving treatment. Second, treating anxiety among Veterans with comorbid PTSD and TBI involves medications that may have limited efficacy (e.g., PTSD medications) or side effects (e.g., drug interactions or diminished cognitive function).
Given these treatment challenges, Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. Briefly, CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain. Additionally, both the Department of Defense (DoD) and Veterans Health Affairs (VHA) prescribe CES to treat trauma-related conditions. CES treatment involves transcutaneous application of pulsed micro-currents of <1000 μA to the patient's head and these currents are tailored specifically for each patient. The studies that have examined efficacy for CES therapy in treating anxiety have shown some positive effects, however, the patient populations were typically small, sometimes limited to case reports, and outcome measures varied significantly. A meta-analysis performed on CES studies over two decades ago found evidence for CES treatment over sham groups, but most of the studies reviewed were missing data and study personnel were not always blinded to the groups. Additionally, CES has showed a significant improvement in anxiety symptoms after of CES therapy in 12 adult patients diagnosed with generalized anxiety disorder (GAD; Bystritsky et al., [2008]). The success of CES in treating anxiety may indicate a suitable signal for exploring its use in PTSD samples (Novakovic et al. [2011]). Given the relatively few CES studies available in the scholarly literature, a 2009 Cochrane Systematic Review found insufficient evidence to support using CES to manage persistent TBI symptoms. While some of these studies are encouraging, the device has not been clearly demonstrated to be effective in the multi-morbid OEF/OIF/OND Veteran population. Additionally, little information is known about the mechanism of action for CES.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CES Therapy | Experimental | Device: CES TherapyAll participants will complete CES treatment over the course of four weeks. Assessments will take place at baseline and at post-test four weeks later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CES TherapyAlso: Cranial Electrotherapy Stimulation (CES) Therapy, Alpha StimCranial 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. | Device | CES Therapy |
Primary outcome
PCL-5 (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders) for Use in Treating PTSD Symptoms
Time frame: 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.
State-Trait Anxiety Inventory (STAI)
Time frame: 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.
Beck Depression Inventory (BDI)
Time frame: 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.
TFI (Tinnitus Functional Index)
Time frame: 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.
MPAI (Mayo Portland Adaptability Inventory)
Time frame: 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.
WAIS (Wechsler Adult Intelligence Scale) Symbol Search
Time frame: 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).
WAIS Coding - Wechsler Adult Intelligence Scale
Time frame: 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.
3 secondary outcomes
Dizziness- NSI (Neurobehavioral Symptom Inventory)
Time frame: Four Weeks
Headache - HIT6 (Headache Impact Test)
Time frame: Four Weeks
Sleep - Pittsburgh Sleep Quality Index (PSQI)
Time frame: Four Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Jaramillo, M.D., Ph.D. principal investigator
San Antonio Polytrauma Center South Texas Veterans Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CES Therapy in people with TBI and Anxiety, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCL-5 (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders) for Use in Treating PTSD Symptoms (time frame: Four Weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018; AzTrials last refreshed its copy on 27 Oct 2026.