Headache, MigraineCOMPASSNCT05302479
Validating a Modified COMPASS 31questionnaire for Treatment Outcomes
An observational study of Headache, Migraine and Persistent Post Traumatic Headache, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Eligible participants will complete the COMPASS 31 (year), modified COMPASS 31(one month) and the NSI (one month) questionnaires at baseline and complete the modified COMPASS 31 and the NSI after usual care of treatment. The investigators will 1. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Headache, Migraine, Persistent Post Traumatic Headache, Cervicogenic Headache
- What is being tested?
- COMPASS 31 questionnaire
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to 20 Sep 2023
- Phase
- Observational
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who present for treatment of headache in the military medical clinic tend to be active duty military patients however retirees and family members will not be excluded from participation.
Who may be able to join
- Patients who present to the BAMC_BIRS clinic for treatment of headache between the ages of 18-64.
Who cannot join
- Normal composite autonomic symptom score.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Centre
Houston, Texas, 78234
Matt Hammerle, matt.h.hammerle.civ@mai.mil
About this study
Official title: Validating the Modified COMPASS 31 Questionnaire for Evaluation and Outcomes of Post-concussive Symptoms in Active Duty Military Patients
Eligible participants will complete the COMPASS 31 (year), modified COMPASS 31(one month) and the NSI (one month) questionnaires at baseline and complete the modified COMPASS 31 and the NSI after usual care of treatment.
The investigators will
- Compare results for the COMPASS 31(year) to the modified COMPASS 31(month) at baseline.
- Compare modified COMPASS 31(month) to the NSI at baseline and post intervention.
Read the detailed description
The Composite Autonomic Symptom Score (COMPASS 31) is a validated questionnaire designed to measure self reported autonomic symptoms in the last year in individuals with migraine and post-concussive symptoms. In order to use this questionnaire to measure response to treatment it would be preferable to determine if the results of the COMPASS 31 are similar if the patient is asked to complete this thinking about symptoms in the last year as per the usual questionnaire, compared to a modified COMPASS 31 where symptoms in the past month will be assessed.
This prospective trial will compare results of the COMPASS 31 (year) to the modified COMPASS 31 (month). Since the present gold standard for outcome measures in post-concussive treatment is the neurobehavioral symptom inventory (NSI), this study will also compare results of the modified COMPASS 31(month) to the NSI outcome measure at baseline and post treatment to validate the utilization of the modified version of the COMPASS 31(month) for use in the post-concussive population as an outcome measure for self-reported autonomic nervous system symptoms.
- Being tested
- COMPASS 31 questionnaire
- Medical subject headings
- Migraine Disorders, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMPASS 31 questionnaireOther
A 31 question questionnaire that measures autonomic symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Autonomic Symptom Score questionnaire (Compass 31)-Self reported autonomic nervous system symptoms in the past year.
Self reported autonomic nervous system symptoms in the past year will be measured using the validated, refined and abbreviated Composite Autonomic Symptom Score questionnaire (Compass 31). Scoring ranges from 0-100 with higher scores indicating more autonomic symptoms.
Measured: One year
Composite Autonomic Symptom Score questionnaire (Compass 31)- Self reported autonomic nervous system symptoms in the past month (COMPASS 31-month).
Self reported autonomic nervous system symptoms in the past month will be measured using the validated, refined and abbreviated Composite Autonomic Symptom Score questionnaire (Compass 31-month). Scoring ranges from 0-100 with higher scores indicating more autonomic symptoms.
Measured: One month
Neurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms.
Neurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms. Scores range from 0-88 with higher scores indicating more symptoms.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Apr 2022
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- The Defense and Veterans Brain Injury Center, The University of Queensland
- Responsible party
- Principal investigator, Matt Hammerle, Brooke Army Medical Center
- Investigators
- Matt H Hammerle, DPT, Principal investigator, BAMC-BIRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302479
- Sponsor's protocol ID
- C.2021.128e
- Acronym
- COMPASS
- Status last verified
- Jul 2022
- First submitted
- 23 Feb 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howard L, Dumkrieger G, Chong CD, Ross K, Berisha V, Schwedt TJ. Symptoms of Autonomic Dysfunction Among Those With Persistent Posttraumatic Headache Attributed to Mild Traumatic Brain Injury: A Comparison to Migraine and Healthy Controls. Headache. 2018 Oct;58(9):1397-1407. doi: 10.1111/head.13396. Epub 2018 Aug 29.
PubMed 30156267King PR, Donnelly KT, Donnelly JP, Dunnam M, Warner G, Kittleson CJ, Bradshaw CB, Alt M, Meier ST. Psychometric study of the Neurobehavioral Symptom Inventory. J Rehabil Res Dev. 2012;49(6):879-88. doi: 10.1682/jrrd.2011.03.0051.
PubMed 23299259
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Modified COMPASS 31 Questionnaire for Evaluation and Outcomes of Post-concussive Symptoms in Active Duty Military Patients
- ClinicalTrials.gov ID
- NCT05302479
- Acronym / sponsor ID
- COMPASS / C.2021.128e
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- The Defense and Veterans Brain Injury Center, The University of Queensland
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 31 Mar 2022 (actual)
- 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.
Eligible participants will complete the COMPASS 31 (year), modified COMPASS 31(one month) and the NSI (one month) questionnaires at baseline and complete the modified COMPASS 31 and the NSI after usual care of treatment.
The investigators will
- Compare results for the COMPASS 31(year) to the modified COMPASS 31(month) at baseline.
- Compare modified COMPASS 31(month) to the NSI at baseline and post intervention.
Detailed description
The Composite Autonomic Symptom Score (COMPASS 31) is a validated questionnaire designed to measure self reported autonomic symptoms in the last year in individuals with migraine and post-concussive symptoms. In order to use this questionnaire to measure response to treatment it would be preferable to determine if the results of the COMPASS 31 are similar if the patient is asked to complete this thinking about symptoms in the last year as per the usual questionnaire, compared to a modified COMPASS 31 where symptoms in the past month will be assessed.
This prospective trial will compare results of the COMPASS 31 (year) to the modified COMPASS 31 (month). Since the present gold standard for outcome measures in post-concussive treatment is the neurobehavioral symptom inventory (NSI), this study will also compare results of the modified COMPASS 31(month) to the NSI outcome measure at baseline and post treatment to validate the utilization of the modified version of the COMPASS 31(month) for use in the post-concussive population as an outcome measure for self-reported autonomic nervous system symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who present for treatment of headache in the military medical clinic tend to be active duty military patients however retirees and family members will not be excluded from participation.
Key inclusion criteria (1 listed)
- Patients who present to the BAMC_BIRS clinic for treatment of headache between the ages of 18-64.
Key exclusion criteria (1 listed)
- Normal composite autonomic symptom score.
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 |
|---|---|---|
| COMPASS 31 questionnaireA 31 question questionnaire that measures autonomic symptoms. | Other | – |
Primary outcome
Composite Autonomic Symptom Score questionnaire (Compass 31)-Self reported autonomic nervous system symptoms in the past year.
Time frame: One year
Self reported autonomic nervous system symptoms in the past year will be measured using the validated, refined and abbreviated Composite Autonomic Symptom Score questionnaire (Compass 31). Scoring ranges from 0-100 with higher scores indicating more autonomic symptoms.
Composite Autonomic Symptom Score questionnaire (Compass 31)- Self reported autonomic nervous system symptoms in the past month (COMPASS 31-month).
Time frame: One month
Self reported autonomic nervous system symptoms in the past month will be measured using the validated, refined and abbreviated Composite Autonomic Symptom Score questionnaire (Compass 31-month). Scoring ranges from 0-100 with higher scores indicating more autonomic symptoms.
Neurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms.
Time frame: One month
Neurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms. Scores range from 0-88 with higher scores indicating more symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 30156267Howard L, Dumkrieger G, Chong CD, Ross K, Berisha V, Schwedt TJ. Symptoms of Autonomic Dysfunction Among Those With Persistent Posttraumatic Headache Attributed to Mild Traumatic Brain Injury: A Comparison to Migraine and Healthy Controls. Headache. 2018 Oct;58(9):1397-1407. doi: 10.1111/head.13396. Epub 2018 Aug 29.
- Background: PubMed 23299259King PR, Donnelly KT, Donnelly JP, Dunnam M, Warner G, Kittleson CJ, Bradshaw CB, Alt M, Meier ST. Psychometric study of the Neurobehavioral Symptom Inventory. J Rehabil Res Dev. 2012;49(6):879-88. doi: 10.1682/jrrd.2011.03.0051.
- 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.
Matt H Hammerle, DPT principal investigator
BAMC-BIRS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, Migraine and Persistent Post Traumatic Headache, run by Brooke Army Medical Center 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 1 inclusion and 1 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 21 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matt H Hammerle, DPT (210-916-8693, matt.h.hammerle.civ@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Autonomic Symptom Score questionnaire (Compass 31)-Self reported autonomic nervous system symptoms in the past year. (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302479, which also lists 2 linked publications.
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 21 Jul 2022.