Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03759808
Status:
UNKNOWN
Last Update Posted:
2021-10-29
First Post:
2018-09-20
Brief Title:
Treatment for Patients With Chronic Post-Concussion Symptoms
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Cognitive Behavioral Treatment for Patients With Chronic Post-Concussion Symptoms
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg catastrophizing to prolonged symptoms of autonomic overactivation after injury eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None