Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 93 of 156 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Brain Injuries, Traumatic

Treatment for Patients With Chronic Post-Concussion Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03759808
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Robert F. Asarnow, Ph.D, 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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Concussion Post Syndrome Behavioral: Psychological Intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: An open trial will be conducted in patients with persistent post-concussion symptoms compared to non-injured controls in order to determine whether the intervention (controlled breathing and cognitive behavioral therapy for anxiety) improves parasympathetic, HPA axis activity and cerebral blood flow, and whether improvement in parasympathetic and HPA axis activity predicts reduction in PPCS symptoms. We will compare baseline evaluations to the evaluation conducted after brief CBT and controlled breathing training to demonstrate the feasibility of normalizing parasympathetic, and HPA axis activity via this intervention. If we obtain the predicted results in the current study we will design a much larger study to identify the mechanisms of change. Healthy, non-injured control participants will provide normative data on all measures except for concussion-relevant outcomes.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: Persistent Post-Concussion Symptoms
Concussed participants with persistent post-concussion symptoms (PPCS) who receive the psychological intervention.
Behavioral: Psychological Intervention
Psychological treatment protocol designed to treat anxiety and avoidance in an adolescent/young adult population. The focus of treatment will be to address cognitive and behavioral factors associated with prolonged symptoms. Cognitive factors that may be addressed include, but are not limited to, catastrophizing, black or white thinking, and false expectations. Behavior factors that may be addressed include, but are not limited to, avoidance, relaxation, and behavioral activation. The psychological intervention is also designed to help reduce psychophysiological arousal associated with anxiety and stress. Participants will also be taught controlled shallow breathing exercises designed to normalize the ratio of sympathetic/parasympathetic activity.




Primary Outcome Measures :
  1. Change in Self-Reported Symptoms After Treatment [ Time Frame: baseline and 6 weeks ]
    Severity of self-reported symptoms on the Post-Concussion Symptom Inventory

  2. Change Self-Reported Quality of Life After Treatment [ Time Frame: baseline and 6 weeks ]
    Self-reported scores on quality of life on Global Quality of Life Scale


Secondary Outcome Measures :
  1. Change in cerebral blood flow stress after treatment [ Time Frame: baseline and 6 weeks ]
    Changes in cerebral blood flow dynamics in bilateral middle cerebral arteries as measured by transcranial doppler.

  2. Change in peak salivary cortisol after treatment [ Time Frame: baseline 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.

  3. Change in respiration rate after treatment [ Time Frame: baseline and 6 weeks ]
    Changes in respiration rate as measured through capnometer in response to stress paradigm

  4. Change in end-tidal carbon dioxide after treatment [ Time Frame: baseline and 6 weeks ]
    Changes in end-tidal carbon dioxide measurement in response to stress paradigm measured through capnometer in mmHg

  5. Change in heart rate after treatment [ Time Frame: baseline and 6 weeks ]
    Changes in heart rate (beats per minute) in response to stress paradigm measured through Biopac system.

  6. Change in blood pressure after treatment [ Time Frame: baseline and 6 weeks ]
    Changes in blood pressure (systolic/dyastolic in mmHg) in response to stress paradigm measured through Biopac system.


Other Outcome Measures:
  1. Change in depressive symptoms after treatment [ Time Frame: baseline and 6 weeks ]
    Self-report measure of cognitive and somatic symptoms of depression, Beck Depression Inventory (BDI-II)

  2. Change in anxiety symptoms after treatment [ Time Frame: baseline and 6 weeks ]
    Self-report measure of cognitive and somatic symptoms of anxiety, Beck Anxiety Inventory (BAI)

  3. Change in sleep quality after treatment [ Time Frame: baseline and 6 weeks ]
    Self-report measure of sleep dysfunction, Pittsburgh Sleep Quality Index (PSQI)

  4. Change in neurocognitive performance after treatment [ Time Frame: baseline and 6 weeks ]
    Selected subtest performance on attention, learning and memory, processing speed, and verbal fluency as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) standardized assessment.

  5. Change in perceived cognitive exertion after treatment [ Time Frame: baseline and 6 weeks ]
    Change in self-reported physical, emotional, and perceived cognitive symptoms from pre- to post-neurocognitive assessment.

  6. Change in illness perception after treatment [ Time Frame: baseline and 6 weeks ]
    Change in self-reported perception of illness as measured by the Brief Illness Perception Questionnaire.

  7. Change in behavioral avoidance and distress after treatment [ Time Frame: baseline and 6 weeks ]
    Change in self-reported behavioral avoidance and distress due to anxiety as measured by the UCLA Behavioral Avoidance and Distress Scale

  8. Change in disability perception due to injury after treatment [ Time Frame: baseline and 6 weeks ]
    Change in self-reported disability in social, occupational, and family/home functioning as measured by the Sheehan Disability Scale

  9. Change in orthostatic blood pressure after treatment [ Time Frame: baseline and 6 weeks ]
    Change in orthostatic blood pressure obtained via measurements in three different positions: supine, upright sitting, and standing, each held for 5 minutes. Measurement obtained via Biopac double finger cuff.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for patients:

  • Between the ages of 13-25
  • Diagnosed with a concussion or mild traumatic brain injury by a physician
  • Currently experiencing post-concussive symptoms for at least two months after their injury but no longer than 9 months.
  • Fluent English speaker

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759808


Contacts
Layout table for location contacts
Contact: Aliyah R Snyder, PhD 3108259121 asnyder@mednet.ucla.edu

Locations
Layout table for location information
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Aliyah R Snyder, PhD    310-825-9121    asnyder@mednet.ucla.edu   
Contact: Alexandra Tanner, MS       tannera@ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Robert Asarnow, PhD University of California, Los Angeles

Layout table for additonal information
Responsible Party: Robert F. Asarnow, Ph.D, Study Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03759808     History of Changes
Other Study ID Numbers: 17-000346
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data that underlie results in a publication will be shared if requested by other researchers. These data will include Study Protocol, Statistical Analysis Plan, and Clinical Study Report. Data will be made available for sharing 6 months after publication and be available for a time frame of 2 years following initial publication. Access to IPD will be considered for researchers with a graduate degree or above for post-hoc analyses or replication efforts. Applications to access individual participant data will be reviewed by principal investigator and appointed co-investigators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 6 months following initial publication, lasting for 2 years after initial publication.
Access Criteria: Access to individual participant data will be considered for researchers with a graduate degree or above for post-hoc analyses or replication efforts. Applications to access individual participant data will be reviewed by principal investigator and appointed co-investigators.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert F. Asarnow, Ph.D, University of California, Los Angeles:
post-concussion syndrome
mild traumatic brain injury
autonomic dysfunction
concussion
capnometry-assisted respiratory training
cognitive behavioral therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Post-Concussion Syndrome
Central Nervous System Diseases
Nervous System Diseases