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Status unknownNCT05302479COMPASSUpdated Jul 21, 2022

Validating a Modified COMPASS 31questionnaire for Treatment Outcomes

An observational study in Headache, Migraine, Persistent Post Traumatic Headache and Cervicogenic Headache, sponsored by Brooke Army Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2022-07-21.

Sponsored by Brooke Army Medical Center · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
18 Years to 64 Years
Sex
All
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Study 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. Compare results for the COMPASS 31(year) to the modified COMPASS 31(month) at baseline.
  2. 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.

02

Conditions studied

  • Headache, Migraine
  • Persistent Post Traumatic Headache
  • Cervicogenic Headache
03

In context

Migraine Disorders

1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.

This study's planned enrollment of 35 is below the median of 130 across 306 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Brooke Army Medical Center is the lead sponsor of 94 studies on the registry; 11 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who present to the BAMC_BIRS clinic for treatment of headache between the ages of 18-64.

Exclusion criteria

Exclusion Criteria:

  • Normal composite autonomic symptom score.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No

Interventions

  • OtherCOMPASS 31 questionnaire

    A 31 question questionnaire that measures autonomic symptoms.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One year

  2. 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.

    Time frame: One month

  3. 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.

    Time frame: One month

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 30156267 ↗
  • King 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2022 (actual). Primary completion is estimated for Sep 2023, 17 months after the start.

Of 117 non-industry observational studies under Migraine Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 63. This study's planned 17 months is below that.

Counting every sponsor, half of 145 studies reached it within 31 months; a quarter within 13 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2022
First posted
Mar 31, 2022
StartActual
Apr 15, 2022
Primary completionEst.
Sep 20, 2023
CompletionEst.
Sep 20, 2023
Last update
Jul 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05302479
Lead sponsor
Brooke Army Medical Center
Collaborators
The Defense and Veterans Brain Injury Center, The University of Queensland
Responsible party
Matt Hammerle (Doctor of Physical Therapy, Brooke Army Medical Center) — Principal investigator
First posted
Mar 31, 2022
Start date
Apr 15, 2022
Primary completion
Sep 20, 2023 (estimated)
Completion
Sep 20, 2023 (estimated)
Last update
Jul 21, 2022

Study contacts

Matt H Hammerle, DPT
Contact
matt.h.hammerle.civ@mail.mil
210-916-8693
Lisa H Lu, PhD
Contact
lisa.h.lu.ctr@mail.mil
210-916-6029
Matt H Hammerle, DPT
principal investigator · BAMC-BIRS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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