Brain ConcussionNCT02699346
An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion
A study testing HS-1000 recording in people with Brain Concussion and Brain Injuries, run by HeadSense Medical at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion, Brain Injuries
- What is being tested?
- HS-1000 recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Timothy Lee, MHA, ATC, 615-875-8722, timothy.lee@vanderbilt.edu
Allen K Sills, MD
About this study
Official title: An Open-Label, Non-Randomized Study Designed to Evaluate the Correlation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion With Clinical Evaluation
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.
Read the detailed description
Concussion diagnosis and assessment suffers from lack of a gold-standard measurement, leaving physicians to rely on physical and neurological examinations, neurocognitive/mental status testing, and balance examination, which can be time-consuming and influenced by subjective factors. In order to address this significant drawback, there is a need for novel modalities that diagnose and monitor concussion in a quick easy-to-use and non-invasive manner.
Based on our previous analysis of the physiological processes using acoustic signals that were collected and analyzed so far, our hypothesis is that the HS-1000 is capable of diagnosing and monitoring concussed patients, based on the acoustic raw data derived from the generated acoustic signal along with the analysis of the acoustic signals that derive from the physiological processes in the brain. These processes, e.g. cerebral blood-flow and the respiratory cycle, are impaired during changes in intracranial pressure (ICP) and are hypothesized to change as well once the patient is concussed.
Concussed athletes will be identified through routine visits at the Vanderbilt Sports Concussion Center. Controls will be identified among non-concussed athletes being seen at Vanderbilt Sports Medicine and will be offered participation.
After signing informed consent, both healthy subjects and patients will undergo screening assessments for this study. Eligible patients and healthy subjects will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears. HS-1000 monitoring intervals will last from 20 minutes continuously. Following completion of data collection, HS-1000 will be removed.
Safety evaluation will include monitoring of adverse events throughout the study.
The study duration for each patient will be up to 1 hour. Healthy subjects will undergo two recordings approximately two weeks apart.
Post-concussion patients will have multiple sessions:
- Session #1 Baseline recording as soon as possible
- Session #2 48 hours after session #1
- Session #3 1 week after session #1
- Session #4 1 month after session #1
- Conditions
- Brain Concussion, Brain Injuries
- Being tested
- HS-1000 recording
- Keywords
- concussion, mild traumatic brain injuries
- Medical subject headings
- Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-1000 recordingDevice
| Study group | Role | What they receive |
|---|---|---|
| HS-1000 recording | Experimental | Eligible patients and healthy subjects will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears. HS-1000 monitoring intervals will last from 20 minutes continuously. Following completion of data collection, HS-1000 will be removed. Receives: Device: HS-1000 recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure ICP values by using the HS-1000 in healthy subjects and concussed subjects
Measured: 20 minute recording session
Determine the correlation between ICP measurements obtained from the HS-1000 device and the clinical findings from the modified Balance Error Score System (mBESS) and ImPACT scores in post-concussion patients.
Measured: 20 minute recording session
Secondary outcomes (1)
To evaluate the ergonomic and functional aspects of using the HS-1000 by having the operators of the device complete a brief 5 question survey about the ease or difficulty in using the device.
Measured: 20 minute recording sessin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeadSense Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Allen K Sills, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699346
- Sponsor's protocol ID
- HS-010
- Status last verified
- Dec 2016
- First submitted
- 26 Feb 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized Study Designed to Evaluate the Correlation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion With Clinical Evaluation
- ClinicalTrials.gov ID
- NCT02699346
- Acronym / sponsor ID
- HS-010
- Conditions
- Brain Concussion, Brain Injuries
- Keywords
- concussion, mild traumatic brain injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HeadSense MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Study start
- Jan 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Concussion diagnosis and assessment suffers from lack of a gold-standard measurement, leaving physicians to rely on physical and neurological examinations, neurocognitive/mental status testing, and balance examination, which can be time-consuming and influenced by subjective factors. In order to address this significant drawback, there is a need for novel modalities that diagnose and monitor concussion in a quick easy-to-use and non-invasive manner.
Based on our previous analysis of the physiological processes using acoustic signals that were collected and analyzed so far, our hypothesis is that the HS-1000 is capable of diagnosing and monitoring concussed patients, based on the acoustic raw data derived from the generated acoustic signal along with the analysis of the acoustic signals that derive from the physiological processes in the brain. These processes, e.g. cerebral blood-flow and the respiratory cycle, are impaired during changes in intracranial pressure (ICP) and are hypothesized to change as well once the patient is concussed.
Concussed athletes will be identified through routine visits at the Vanderbilt Sports Concussion Center. Controls will be identified among non-concussed athletes being seen at Vanderbilt Sports Medicine and will be offered participation.
After signing informed consent, both healthy subjects and patients will undergo screening assessments for this study. Eligible patients and healthy subjects will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears. HS-1000 monitoring intervals will last from 20 minutes continuously. Following completion of data collection, HS-1000 will be removed.
Safety evaluation will include monitoring of adverse events throughout the study.
The study duration for each patient will be up to 1 hour. Healthy subjects will undergo two recordings approximately two weeks apart.
Post-concussion patients will have multiple sessions:
- Session #1 Baseline recording as soon as possible
- Session #2 48 hours after session #1
- Session #3 1 week after session #1
- Session #4 1 month after session #1
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-1000 recording | Experimental | Device: HS-1000 recordingEligible patients and healthy subjects will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears. HS-1000 monitoring intervals will last from 20 minutes continuously. Following completion of data collection, HS-1000 will be removed. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Healthy subjects with no previous concussions:
- Post-concussion diagnosed patients:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-1000 recording | Device | HS-1000 recording |
Primary outcome
To measure ICP values by using the HS-1000 in healthy subjects and concussed subjects
Time frame: 20 minute recording session
Determine the correlation between ICP measurements obtained from the HS-1000 device and the clinical findings from the modified Balance Error Score System (mBESS) and ImPACT scores in post-concussion patients.
Time frame: 20 minute recording session
1 secondary outcome
To evaluate the ergonomic and functional aspects of using the HS-1000 by having the operators of the device complete a brief 5 question survey about the ease or difficulty in using the device.
Time frame: 20 minute recording sessin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen K Sills, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HS-1000 recording in people with Brain Concussion and Brain Injuries, run by HeadSense Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tricia Kwiatkowski, M.D. (301-717-2657, tricia@head-sense-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure ICP values by using the HS-1000 in healthy subjects and concussed subjects (time frame: 20 minute recording session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016.