Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-22 @ 12:54 AM
Study NCT ID:
NCT02699359
Status:
UNKNOWN
Last Update Posted:
2019-10-30
First Post:
2016-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
Sponsor:
HeadSense Medical
Organization:
Study Overview
Official Title:
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
Status:
UNKNOWN
Status Verified Date:
2016-12
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 HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic signal analysis to calculate ICP on a continuous basis. Initial HS-1000 clinical data also shows promise in assessing a variety of cerebral hemodynamic parameters such as cerebral blood-flow, auto regulation monitoring, and cerebrovascular vessels compliance. In the absence of a non-invasive monitor of intracranial pressure (ICP), the relationships, if any, that may exist between concussion, timing of the concussion (e.g. acute, resolving, resolved) and ICP is unknown. The new HS-1000 non-invasive device may provide insight into assessment of possible ICP changes following concussion in children.
Detailed Description:
Unlike fractures, concussion can be difficult to recognize and diagnose, given lack of specific diagnostic tests or clinical findings. Current diagnostic recommendations include a multi-factorial approach involving symptom inventory, baseline and post-injury neuropsychological assessment, and balance testing.
Lacking from this paradigm is a truly objective measure of physiological changes associated with concussion. In addition, post-concussion symptoms are unique to each individual and vary in occurrence, degree, and severity. For these reasons, a clinical diagnosis of concussion should be made by a healthcare provider familiar with the athlete and knowledgeable in concussion symptom recognition and evaluation.
This study aims to determine ICP measurements derived from the HS-1000 non-invasive device in children and adolescents seen in the Akron Children's Hospital Sports Medicine Clinic for concussion (anytime during their care) compared to ICP values obtained in age and gender matched Akron Children's Hospital Sports Medicine Clinic patients with no history of head injury.
Patients with a history and/or symptoms of head trauma cared for in the Akron Children's Hospital Sports Medicine Clinic will be invited to participate in this study. Study participants will receive HS-1000 ICP readings for a continuous 16 minute interval in a 30 degree supine position. Recordings will be obtained in one session. When possible, these recordings will be obtained at their initial examination and all follow-up visits. Sports Medicine staff will coordinate the HS-1000 device earplug insertion and recordings so as not to interfere with, nor marginally delay the patient's normal, routine clinical evaluation.
Lacking from this paradigm is a truly objective measure of physiological changes associated with concussion. In addition, post-concussion symptoms are unique to each individual and vary in occurrence, degree, and severity. For these reasons, a clinical diagnosis of concussion should be made by a healthcare provider familiar with the athlete and knowledgeable in concussion symptom recognition and evaluation.
This study aims to determine ICP measurements derived from the HS-1000 non-invasive device in children and adolescents seen in the Akron Children's Hospital Sports Medicine Clinic for concussion (anytime during their care) compared to ICP values obtained in age and gender matched Akron Children's Hospital Sports Medicine Clinic patients with no history of head injury.
Patients with a history and/or symptoms of head trauma cared for in the Akron Children's Hospital Sports Medicine Clinic will be invited to participate in this study. Study participants will receive HS-1000 ICP readings for a continuous 16 minute interval in a 30 degree supine position. Recordings will be obtained in one session. When possible, these recordings will be obtained at their initial examination and all follow-up visits. Sports Medicine staff will coordinate the HS-1000 device earplug insertion and recordings so as not to interfere with, nor marginally delay the patient's normal, routine clinical evaluation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: