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Treatment for Patients With Chronic Post-Concussion Symptoms

Not Applicable
Conditions
Mild Traumatic Brain Injury
Concussion Post Syndrome
Interventions
Behavioral: Psychological Intervention
Registration Number
NCT03759808
Lead Sponsor
University of California, Los Angeles
Brief Summary

The current project will examine the effect of a brief psychological intervention on post-concussion symptoms, neurocognitive function, cerebral blood flow (CBF), and psychophysiological and salivary cortisol markers of autonomic nervous system (ANS) in a sample of 20 participants between 13-25 years of age who experience long-term post-concussive (PC) symptoms 2-9 months post-injury as well as 20 age- and sex-matched controls (non-injured) participants to provide normative data on all the above measures except for concussive symptoms.

Detailed Description

Participants with concussion will participate in six, home-based interventions designed to treat cognitive-behavioral factors that are maintaining their symptoms. The investigators hypothesize that the prolonged PC symptoms are in part due to disruption of autonomic nervous system function post-injury as well as exacerbation by the psychological response to the injury. This hypothesis is based on evidence showing that PC symptoms, including headache, fatigue, dizziness, and heightened anxiety overlap with upregulated sympathetic activity and elevated levels of salivary cortisol. There is evidence linking cognitive-behavioral factors (e.g., catastrophizing) to prolonged symptoms of autonomic overactivation after injury (e.g., anxiety, pain, etc.). The participants are taught shallow breathing techniques to normalize parasympathetic activity and provide cognitive-behavioral treatment to reduce psychological reactions to the injury that exacerbate the autonomic disruption and prolong recovery.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

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Exclusion Criteria
  • History of/or comorbid neurological conditions that might affect performance (including history of stroke, seizure disorder, moderate to severe traumatic brain injury, anoxia)
  • Severe cardiovascular conditions.
  • History of psychosis and current substance abuse or dependence.
  • Current severe symptoms of depression and/or anxiety.

Additional Exclusion Criteria for Controls:

* No history of concussion in the past year.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Persistent Post-Concussion SymptomsPsychological InterventionConcussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention.
Primary Outcome Measures
NameTimeMethod
Change in Self-Reported Symptoms After Treatmentbaseline and 6 weeks

Severity of self-reported symptoms on the Post-Concussion Symptom Inventory

Change Self-Reported Quality of Life After Treatmentbaseline and 6 weeks

Self-reported scores on quality of life on Global Quality of Life Scale

Secondary Outcome Measures
NameTimeMethod
Change in peak salivary cortisol after treatmentbaseline and 6 weeks

Changes in peak salivary cortisol concentration will be measured in response to stress paradigm. Measurements will be taken just prior to stress paradigm and then 20 minutes after its conclusion.

Change in end-tidal carbon dioxide after treatmentbaseline and 6 weeks

Changes in end-tidal carbon dioxide measurement in response to stress paradigm measured through capnometer in mmHg

Change in cerebral blood flow stress after treatmentbaseline and 6 weeks

Changes in cerebral blood flow dynamics in bilateral middle cerebral arteries as measured by transcranial doppler.

Change in heart rate after treatmentbaseline and 6 weeks

Changes in heart rate (beats per minute) in response to stress paradigm measured through Biopac system.

Change in respiration rate after treatmentbaseline and 6 weeks

Changes in respiration rate as measured through capnometer in response to stress paradigm

Change in blood pressure after treatmentbaseline and 6 weeks

Changes in blood pressure (systolic/dyastolic in mmHg) in response to stress paradigm measured through Biopac system.

Trial Locations

Locations (1)

University of California, Los Angeles

🇺🇸

Los Angeles, California, United States

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