Healthy VolunteerNCT01629901
Caloric Stimulation on Cerebral Blood Flow
A study testing ThermoNeuroModulation (TNM) Device in people with Healthy Volunteer, run by Duke University at 1 site in United States.
Trial summary
This is a prospective, non-randomized study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral blood flow on normal healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ThermoNeuroModulation (TNM) Device
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Apr 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no history of neurological disease
Who cannot join
- persons under the age of 18
- pregnant or nursing women
- history of neurological disease
- history of psychiatric disease
- congenital heart defect, known cardiac shunt
- inner ear or pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: The Effect of Vestibular Stimulation on Cerebral Blood Flow
This is a prospective, non-randomized study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral blood flow on normal healthy volunteers.
Read the detailed description
Study activities include monitoring with bilateral transcranial Doppler (TCD), EEG and continuous EKG monitoring at 30 second intervals for 5 minutes. This is followed by placement of the caloric stimulator investigational device for 20 minutes. An additional 20 minutes of TCD and EEG monitoring will also be recorded. This will end study participation.
- Conditions
- Healthy Volunteer
- Being tested
- ThermoNeuroModulation (TNM) Device
- Keywords
- Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermoNeuroModulation (TNM) DeviceDevice
Non-invasive neurostimulator used for up to 20 minutes in a session.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebral blood flow
Changes in cerebral blood flow will be quantified through the use of bilateral transcranial Doppler (TCD). The baseline TCD of three vessels will be compared with measurements taken at 30 second intervals for 5 minutes after caloric stimulation.
Measured: 20 minutes
Secondary outcomes (2)
Alterations in EEG readings
EEG readings occurring between baseline, active CVS induction, and post-CVS induction periods will be assessed to identify and characterize alterations in the readings.
Measured: 40 minutes
Alterations in regional cerebral brain flow (rCBF)
A standard noninvasive near infrared spectroscopy system will be used to look for any alterations in rCBF induced by CVS treatment.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Scion NeuroStim
- Responsible party
- Sponsor
- Investigators
- Daniel Laskowitz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629901
- Sponsor's protocol ID
- Pro00035775
- Status last verified
- Jun 2015
- First submitted
- 26 Jun 2012
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Stimulation on Cerebral Blood Flow
- ClinicalTrials.gov ID
- NCT01629901
- Acronym / sponsor ID
- Pro00035775
- Conditions
- Healthy Volunteer
- Keywords
- Healthy volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Scion NeuroStim
- Study start
- Jun 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Jun 2012 (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.
This is a prospective, non-randomized study designed to generate preliminary data to assess the effect of a new portable non-invasive caloric stimulator on EEG waveform and cerebral blood flow on normal healthy volunteers.
Detailed description
Study activities include monitoring with bilateral transcranial Doppler (TCD), EEG and continuous EKG monitoring at 30 second intervals for 5 minutes. This is followed by placement of the caloric stimulator investigational device for 20 minutes. An additional 20 minutes of TCD and EEG monitoring will also be recorded. This will end study participation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- no history of neurological disease
Key exclusion criteria (6 listed)
- persons under the age of 18
- pregnant or nursing women
- history of neurological disease
- history of psychiatric disease
- congenital heart defect, known cardiac shunt
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 |
|---|---|---|
| ThermoNeuroModulation (TNM) DeviceNon-invasive neurostimulator used for up to 20 minutes in a session. | Device | – |
Primary outcome
Changes in cerebral blood flow
Time frame: 20 minutes
Changes in cerebral blood flow will be quantified through the use of bilateral transcranial Doppler (TCD). The baseline TCD of three vessels will be compared with measurements taken at 30 second intervals for 5 minutes after caloric stimulation.
2 secondary outcomes
Alterations in EEG readings
Time frame: 40 minutes
Alterations in regional cerebral brain flow (rCBF)
Time frame: 40 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
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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.
Daniel Laskowitz, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThermoNeuroModulation (TNM) Device in people with Healthy Volunteer, run by Duke University 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 1 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: finished, as of the sponsor's last update on 21 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cerebral blood flow (time frame: 20 minutes). 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 21 Mar 2017.