Combat Related SymptomsCESNCT00866411
Cranial Electrotherapy Stimulation (CES) for Soldiers With Combat-Related Symptoms
A study testing cranial electrotherapy stimulation (CES) with Alpha-Stim in people with Combat Related Symptoms and Irritability, run by Brooke Army Medical Center at 2 sites in United States.
Trial summary
The purpose of this double-blind randomized control research study is to determine if CES given in a group setting for soldiers experiencing irritability is effective to reduce the symptom of irritability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Combat Related Symptoms, Irritability, Anger
- What is being tested?
- cranial electrotherapy stimulation (CES) with Alpha-Stim
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Soldiers over 18 years old or emancipated minors willing to sign an informed consent and complete all protocol requirements.
- Soldiers who score 4 or greater on the visual analog scale for irritability
Who cannot join
- Seizure disorders.
- Pregnancy. All female Soldiers will verify in the informed consent that they are not currently pregnant. Safety of stimulation has not been established during pregnancy and therefore we will exclude women who are or want to become pregnant during the course of the study.
- Concomitant therapy with an investigational drug or device, or participation in an investigational drug or device study within one month prior to entering this study
- Patients with a pacemaker or implanted defibrillator. The Alpha-Stim 100 may effect the operation of cardiac pacemakers (particularly demand type pacemakers) and therefore this population will be excluded from this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544
Sharon Reese, AN, DrPH, 254-288-8577, sharon.reese@amedd.army.mil
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Mona O Bingham, PhD, 210-916-7159, mona.bingham@amedd.army.mil
Stacey Young-McCaughan, PhD, (210) 567-1942, stacey.young-mccaughan@us.army.mil
About this study
Official title: Outcomes of Cranial Electrotherapy Stimulation (CES) With Soldiers for Combat-Related Symptoms
The purpose of this double-blind randomized control research study is to determine if CES given in a group setting for soldiers experiencing irritability is effective to reduce the symptom of irritability.
- Conditions
- Combat Related Symptoms, Irritability, Anger
- Being tested
- cranial electrotherapy stimulation (CES) with Alpha-Stim, placebo
- Keywords
- cranial electrotherapy stimulation, anxiety, depression, pain, sleep disturbance, combat exposure, post traumatic stress, health status, medication use, soldiers
- Medical subject headings
- Anxiety Disorders, Depression, Pain, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranial electrotherapy stimulation (CES) with Alpha-StimProcedure or surgery
Also called cranial electrotherapy stimulation, CES, Alpha-Stim, bioelectric medicine
three weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments)
placeboProcedure or surgery
three weeks of placebo treatment via a double-blinded procedure so that neither the Soldier nor the study investigators will know whether the Soldier is receiving the actual treatment or placebo
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritability Visual Analog Scale
Measured: Baseline, daily x 3 weeks, 4 weeks
Secondary outcomes (16)
State Anxiety Scale
Measured: Baseline, 3 weeks, 4 weeks
Pittsburgh Sleep Quality Index
Measured: Baseline, 3 weeks, 4 weeks
Epworth Sleepiness Scale
Measured: Baseline, 3 weeks, 4 weeks
General Sleep Disturbance Scale
Measured: Baseline, 3 weeks, 4 weeks
Sleep Self Care Questionnaire
Measured: Baseline, 3 weeks, 4 weeks
Combat Exposure Scale
Measured: Baseline
Trauma Imagery Scale
Measured: Baseline, 3 weeks, 4 weeks
State - Anxiety Scale
Measured: Baseline, 3 weeks, 4 weeks
Profile of Mood States
Measured: Baseline, 3 weeks, 4 weeks
Visual Analog
Measured: Daily x 3 weeks, 4 weeks
Center for Epidemiological Center for Epidemiological Studies - Depression Scale
Measured: Baseline, 3 weeks, 4 weeks
Depression Visual Analog
Measured: Daily x 3 weeks, 4 weeks
PTSD CheckList - Military Version
Measured: Baseline, 3 weeks, 4 weeks
Veteran's Outcomes Survey Short Form - 36
Measured: Baseline, 3 weeks, 4 weeks
Medication Use Questionnaire
Measured: Baseline, 3 weeks, 4 weeks
Spielberger State-Trait Anger Expression Inventory-2(STAXI-2)
Measured: baseline, 3 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startMay 2007
- Primary completionMay 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combat Related SymptomsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Mona O Bingham, PhD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866411
- Sponsor's protocol ID
- C.2007.147
- Acronym
- CES
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2009
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Cranial Electrotherapy Stimulation (CES) With Soldiers for Combat-Related Symptoms
- ClinicalTrials.gov ID
- NCT00866411
- Acronym / sponsor ID
- CES / C.2007.147
- Conditions
- Combat Related Symptoms, Irritability, Anger
- Keywords
- cranial electrotherapy stimulation, anxiety, depression, pain, sleep disturbance, combat exposure, post traumatic stress, health status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- May 2007
- Primary completion
- May 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this double-blind randomized control research study is to determine if CES given in a group setting for soldiers experiencing irritability is effective to reduce the symptom of irritability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Soldiers over 18 years old or emancipated minors willing to sign an informed consent and complete all protocol requirements.
- Soldiers who score 4 or greater on the visual analog scale for irritability
Key exclusion criteria (4 listed)
- Seizure disorders.
- Pregnancy. All female Soldiers will verify in the informed consent that they are not currently pregnant. Safety of stimulation has not been established during pregnancy and therefore we will exclude women who are or want to become pregnant during the course of the study.
- Concomitant therapy with an investigational drug or device, or participation in an investigational drug or device study within one month prior to entering this study
- Patients with a pacemaker or implanted defibrillator. The Alpha-Stim 100 may effect the operation of cardiac pacemakers (particularly demand type pacemakers) and therefore this population will be excluded from this study.
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 |
|---|---|---|
| cranial electrotherapy stimulation (CES) with Alpha-StimAlso: cranial electrotherapy stimulation, CES, Alpha-Stim, bioelectric medicinethree weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments) | Procedure or surgery | – |
| placebothree weeks of placebo treatment via a double-blinded procedure so that neither the Soldier nor the study investigators will know whether the Soldier is receiving the actual treatment or placebo | Procedure or surgery | – |
Primary outcome
Irritability Visual Analog Scale
Time frame: Baseline, daily x 3 weeks, 4 weeks
16 secondary outcomes
State Anxiety Scale
Time frame: Baseline, 3 weeks, 4 weeks
Pittsburgh Sleep Quality Index
Time frame: Baseline, 3 weeks, 4 weeks
Epworth Sleepiness Scale
Time frame: Baseline, 3 weeks, 4 weeks
General Sleep Disturbance Scale
Time frame: Baseline, 3 weeks, 4 weeks
Sleep Self Care Questionnaire
Time frame: Baseline, 3 weeks, 4 weeks
Combat Exposure Scale
Time frame: Baseline
Trauma Imagery Scale
Time frame: Baseline, 3 weeks, 4 weeks
State - Anxiety Scale
Time frame: Baseline, 3 weeks, 4 weeks
Profile of Mood States
Time frame: Baseline, 3 weeks, 4 weeks
Visual Analog
Time frame: Daily x 3 weeks, 4 weeks
Center for Epidemiological Center for Epidemiological Studies - Depression Scale
Time frame: Baseline, 3 weeks, 4 weeks
Depression Visual Analog
Time frame: Daily x 3 weeks, 4 weeks
PTSD CheckList - Military Version
Time frame: Baseline, 3 weeks, 4 weeks
Veteran's Outcomes Survey Short Form - 36
Time frame: Baseline, 3 weeks, 4 weeks
Medication Use Questionnaire
Time frame: Baseline, 3 weeks, 4 weeks
Spielberger State-Trait Anger Expression Inventory-2(STAXI-2)
Time frame: baseline, 3 weeks, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2009.
Related trials for Combat Related Symptoms
Not yet recruiting
Blast-related Regional Anaesthesia and Peripheral nerVe Injury Evaluation
Nerve Block, Nerve Blocks
Not yet recruitingObservational study
DRONE-WOUND Study: Severe Infection After Drone-Related Combat Trauma
Combat Related Symptoms, Combat Trauma
Recruiting
Effectiveness, Implementation, and Cost of Cognitive Processing Therapy in Prisons
PTSD - Post Traumatic Stress Disorder, PTSD and Alcohol Use Disorder
Not yet recruiting
Bridging Affect Consciousness, Mentalization and Trauma- Exploring an Integrative Treatment Approach for Personality Disorder (PD).
Personality Disorder, Borderline, Personality Trait
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.
Mona O Bingham, PhD principal investigator
Brooke Army Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cranial electrotherapy stimulation (CES) with Alpha-Stim in people with Combat Related Symptoms and Irritability, run by Brooke Army Medical Center at 2 sites 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritability Visual Analog Scale (time frame: Baseline, daily x 3 weeks, 4 weeks). 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 20 Mar 2009; AzTrials last refreshed its copy on 7 Nov 2026.