Post Traumatic Stress Disorder PTSDNCT02247570
Vestibular Rehabilitation Strategies in PTSD Effectiveness of Carrick Brain Centers Strategies Vestibular Rehabilitation Treatment in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries
A study testing Vestibular Rehabilitation in people with Post Traumatic Stress Disorder PTSD, run by Carrick Institute for Graduate Studies at 1 site in United States.
Trial summary
The specific aim of this proposed study is to compare the effectiveness of Vestibular Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain injuries in a randomized controlled trial in terms of PTSD symptom reduction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD
- What is being tested?
- Vestibular Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Feb 2015
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Veterans with extended combat exposure, confirmed by DD-214 with combat medal and honorable discharge.
- Ages 18-60.
- Texas residents (Per funding agency).
- Medical history of TBI/head injury which occurred through military service.
- Previous medical diagnosis of PTSD or currently suffering from PTSD-like symptoms.
- Have attempted at least two of the following therapies with no significant outcome, or intolerable adverse effects: Anti-psychotic therapy (eg. Seroquel), SSRI therapy (i.e. Fluoxitiene, Celexa, etc), Atypical antidepressant therapy (Wellbutrin), Cognitive Behavior Therapy, Desensitization/exposure therapy, another form of Psychotherapy ("Talk" therapy), EMDR, or any other recognized therapy indicated for PTSD.
Who cannot join
- Concurrent therapy, including concurrent psychotherapy or pharmaceutical therapy.
- Currently addicted to alcohol or an illegal substance. If you have been through an inpatient program, you must have been released at least 90 days prior to treatment start date and have remained free from drugs and alcohol since the release from inpatient.
- Threat of harm to self and/or others
- Psychotic disorder that would prevent compliance (e.g. dissociative disorder, schizophrenia, history of catatonic states).
- Physical condition that would prevent any part of the treatment from being conducted in a safe and complete manner.
- Concussion within the last 30 days.
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- History of stroke.
- Neurodegenerative disease.
- History of brain surgery, which included the removal of brain tissue.
- Previously convicted of a felony crime.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparison of the Effectiveness of Carrick Brain Centers Strategies Vestibular Rehabilitation Treatment in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries.
The specific aim of this proposed study is to compare the effectiveness of Vestibular Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain injuries in a randomized controlled trial in terms of PTSD symptom reduction.
Read the detailed description
The study has been approved by our Institutional IRB and conducted in accordance with the principles of the Declaration of Helsinki. The trial will be registered at Clinicaltrials.gov, a service of the U.S. National Institutes of Health. There is equipoise. This randomized controlled trial will compare the effectiveness of VR in in patients with PTSD who have suffered combat related traumatic brain injuries. A blinded investigator that will not be involved in the study will perform the randomization and allocation procedure.
We will accomplish the specific aim of our study by analyzing the difference in the Clinician Administered DSM-IV PTSD Scale (CAPS) scores between the two groups in our study as outcomes to compare the effectiveness of VR. The CAPS is considered to be the gold standard for diagnosing PTSD and assessing symptom severity. We expect differences in the outcomes between both treatments to be immediate and at follow-up over time, i.e. immediately after 3 months, 6 months and 12 months after cessation of a 2 week treatment period. The study design will include one pre-treatment assessment and our post-treatment assessments (at 3 months, 6 months and 12 months). Investigators who will be blinded for the allocated treatment will perform all assessments. The study will be performed at the department of Neurology of our Institutional Brain Center in Dallas, Texas. Patient recruitment will begin starting in September 2014.
- Conditions
- Post Traumatic Stress Disorder PTSD
- Being tested
- Vestibular Rehabilitation
- Keywords
- Vestibular Rehabilitation, PTSD, DSM-IV
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular RehabilitationProcedure or surgery
Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation | Experimental | Vestibular Rehabilitation Receives: Procedure: Vestibular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DSM-IV CAPS
Neuropsychiatric evaluation using gold standard DSM-IV protocols
Measured: pre and post treatment and 3 months, 6 months and 1 year
Secondary outcomes (3)
Change in Computerized Dynamic Posturography
Force plate measurement of center of pressure and limits of stability
Measured: pre and post treatment and 3 months, 6 months and 1 year
Change in Saccadometry/VNG
Measurement of visual fixation, saccades, pursuits and optokinetic responses
Measured: pre and post treatment and 3 months, 6 months and 1 year
Change in ImPACT testing
Validated neuropsychological computerized testing
Measured: pre and post treatment and 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder PTSDStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Institute for Graduate Studies
- Sponsor type
- University, hospital or other
- Collaborators
- Carrick Brain Centers
- Responsible party
- Principal investigator, Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
- Investigators
- Frederick R Carrick, PhD, Principal investigator, Carrick Brain Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247570
- Sponsor's protocol ID
- 2014-CBC-03
- Status last verified
- Jan 2016
- First submitted
- 18 Sep 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparison of the Effectiveness of Carrick Brain Centers Strategies Vestibular Rehabilitation Treatment in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries.
- ClinicalTrials.gov ID
- NCT02247570
- Acronym / sponsor ID
- 2014-CBC-03
- Conditions
- Post Traumatic Stress Disorder PTSD
- Keywords
- Vestibular Rehabilitation, PTSD, DSM-IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Collaborators
- Carrick Brain Centers
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Sep 2014 (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 specific aim of this proposed study is to compare the effectiveness of Vestibular Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain injuries in a randomized controlled trial in terms of PTSD symptom reduction.
Detailed description
The study has been approved by our Institutional IRB and conducted in accordance with the principles of the Declaration of Helsinki. The trial will be registered at Clinicaltrials.gov, a service of the U.S. National Institutes of Health. There is equipoise. This randomized controlled trial will compare the effectiveness of VR in in patients with PTSD who have suffered combat related traumatic brain injuries. A blinded investigator that will not be involved in the study will perform the randomization and allocation procedure.
We will accomplish the specific aim of our study by analyzing the difference in the Clinician Administered DSM-IV PTSD Scale (CAPS) scores between the two groups in our study as outcomes to compare the effectiveness of VR. The CAPS is considered to be the gold standard for diagnosing PTSD and assessing symptom severity. We expect differences in the outcomes between both treatments to be immediate and at follow-up over time, i.e. immediately after 3 months, 6 months and 12 months after cessation of a 2 week treatment period. The study design will include one pre-treatment assessment and our post-treatment assessments (at 3 months, 6 months and 12 months). Investigators who will be blinded for the allocated treatment will perform all assessments. The study will be performed at the department of Neurology of our Institutional Brain Center in Dallas, Texas. Patient recruitment will begin starting in September 2014.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation | Experimental | Procedure: Vestibular RehabilitationVestibular Rehabilitation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Veterans with extended combat exposure, confirmed by DD-214 with combat medal and honorable discharge.
- Ages 18-60.
- Texas residents (Per funding agency).
- Medical history of TBI/head injury which occurred through military service.
- Previous medical diagnosis of PTSD or currently suffering from PTSD-like symptoms.
Key exclusion criteria (10 listed)
- Concurrent therapy, including concurrent psychotherapy or pharmaceutical therapy.
- Currently addicted to alcohol or an illegal substance. If you have been through an inpatient program, you must have been released at least 90 days prior to treatment start date and have remained free from drugs and alcohol since the release from inpatient.
- Threat of harm to self and/or others
- Psychotic disorder that would prevent compliance (e.g. dissociative disorder, schizophrenia, history of catatonic states).
- Physical condition that would prevent any part of the treatment from being conducted in a safe and complete manner.
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 |
|---|---|---|
| Vestibular RehabilitationStimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training | Procedure or surgery | Vestibular Rehabilitation |
Primary outcome
Change in DSM-IV CAPS
Time frame: pre and post treatment and 3 months, 6 months and 1 year
Neuropsychiatric evaluation using gold standard DSM-IV protocols
3 secondary outcomes
Change in Computerized Dynamic Posturography
Time frame: pre and post treatment and 3 months, 6 months and 1 year
Change in Saccadometry/VNG
Time frame: pre and post treatment and 3 months, 6 months and 1 year
Change in ImPACT testing
Time frame: pre and post treatment and 3 months, 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Frederick R Carrick, PhD principal investigator
Carrick Brain Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation in people with Post Traumatic Stress Disorder PTSD, run by Carrick Institute for Graduate Studies 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 6 inclusion and 10 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 27 Jan 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in DSM-IV CAPS (time frame: pre and post treatment and 3 months, 6 months and 1 year). 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 27 Jan 2016.