An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion
Status unconfirmed · Not applicable
Conditions studied: Brain Concussion, Brain Injuries
In brief
The HeadSense (HS) HS-1000 device, a new non-invasive brain monitor is expected to safely and accurately monitor concussed patients with minimal discomfort, potentially providing a new modality for concussion measurement. The device is based on advanced signal analysis algorithms that analyze a very low frequency acoustic signal (within the audible range) generated by the device. The acoustic signal is transmitted using a small transmitter, placed in the participant's ear, and picked by an acoustic sensor placed in the other ear.
Key facts
- Study ID
- NCT02699346
- Run by
- HeadSense Medical
- People needed
- 100
- Starts
- 2015-01-01
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2016-12-22
Who can join
Age: 13 and older, up to 25. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy subjects with no previous concussions:
- Male or female subjects, aged 13 - 25 years old at screening visit
- Subjects who were previously diagnosed by standard methods as healthy subjects with no previous concussions
- Subject is able and willing to comply with the requirements of the protocol
- Subject is able to understand and sign written informed consent to participate in the study
- Post-concussion diagnosed patients:
- Male or female subjects, aged 13-25 years at screening visit
- Subjects who were previously diagnosed by standard methods as suffering from concussion
- Subject is able and willing to comply with the requirements of the protocol
- Subject is able to understand and sign written informed consent to participate in the study
You may not qualify if…
- Local ear infection
- Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
- Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
- Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent
- History of psychiatric illness, chemical dependency, Attention-Deficit Hyperactivity Disorder (ADHD), Learning Disability, seizure disorder, prior neurosurgical intervention
- Current use of psychotropic medication
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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