Cerebrospinal Fluid Pressure IncreasedEarly Phase 1NCT03757897
The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics.
A Early Phase 1 study testing Dexmedetomidine in people with Cerebrospinal Fluid Pressure Increased, run by Yale University.
Trial summary
The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrospinal Fluid Pressure Increased
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2022
- Phase
- Early Phase 1
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Males or females between 18 and 40 years of age. Determined to be American Society of Anesthesiologist (ASA) 1 subjects.
- Ability to provide written informed consent.
Who cannot join
- Subjects with potential difficult airway as determined by the anesthesiologist
- History of or family history of difficulty with anesthesia or sedation procedures
- Known intolerance to dexmedetomidine
- Body mass index >30
- Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or abnormal sleeping patterns (including but not limited to those who use a Continuous positive Airway Pressure (C-PAP) machine, sleeping during the day, using medication to fall asleep, subjects reporting snoring as determined by self- report using Snoring, Tiredness, Observed apnea, Blood pressure, Body mass index, Age, Neck circumference and Gender (STOP-BANG) questionnaire (i) for undiagnosed OSA (3 or more 'yes' answers will exclude) and/or medical history;
- Subjects with a history of restless leg syndrome as determined by self-report and/or medical history;
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- Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or medications that may affect brain function (including but not limited to opioid analgesics, antidepressants, antipsychotics, benzodiazepines and barbiturates) as determined by self-report and/or medical history;
- Current or past Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of a psychiatric disorder if it was severe enough to require the use of medications and or hospitalization to treat the condition.
- Major medical problems that can impact brain function (e.g., problems of the Central Nervous System including seizures and psychosis; cardiovascular disease including hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report, medical history and/or clinical exam;
- Hepatic dysfunction or impairment as determined by subjects' self-reported history
- Head trauma with loss of consciousness for more than 60 minutes as determined by self-report and/or medical history;
- Positive urine test for controlled substances (cocaine, methamphetamine, amphetamines, opioids, cannabinoids, benzodiazepines and barbiturates) at the screening visit and at each visit of imaging study and neuropsychological assessment;
- Positive urine pregnancy test;
- Nursing mothers will be excluded
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, large tattoos, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces as determined by the self-report checklist.
- Fear of enclosed spaces (claustrophobia) as determined by self-report and medical history.
- Cannot lie comfortably flat on the back for up to 3 hours in the MRI scanner as determined by self- report.
About this study
Official title: The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics
The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal.
Read the detailed description
The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal:
- Resting, awake state
- During sleep with low-dose intravenous infusion of dexmedetomidine (titrated to a Bispectral index (BIS) of 60-70)
- Conditions
- Cerebrospinal Fluid Pressure Increased
- Being tested
- Dexmedetomidine
- Keywords
- dexmedetomidine
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called DEXM
The standard dosing of 1mcg/kg will be implemented over 10 minutes followed by a maintenance infusion of 0.2-1.0 titrated to a the target BIS (60-70) during the 20 minutes prior to MRI.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine induced sleep patients | Experimental | All subjects will be measured for CSF volume, diffusion parameters and mechanical 'stiffness' of the brain during wakefulness and during sleep-induced with dexmedetomidine (DEXM). Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF volume increase by 10%
We hypothesize that CSF volume (as measured by T1 relaxation) will expand by 10% with DEXM- induced sleep compared to wakefulness. The increase in CSF volume during DEXM-induced sleep occurs because DEXM lowers central norepinephrine tone and sleep causes an increase in the interstitial fluid (ISF) volume (cell volume shrinks). MRI will take place 30 minutes after dexmedetomidine infusion.
Measured: 2 hours 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: The investigators were unable to implement a MRI compatible EEG for use in human subjects (equipment and technical issues).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid Pressure IncreasedStudies of the same condition, open and under way.
- More trials run by Yale 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a preliminary interventional trial in which participants will serve as their own controls.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Benveniste, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757897
- Sponsor's protocol ID
- 2000024166
- Status last verified
- May 2022
- First submitted
- 27 Nov 2018
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics
- ClinicalTrials.gov ID
- NCT03757897
- Acronym / sponsor ID
- 2000024166
- Conditions
- Cerebrospinal Fluid Pressure Increased
- Keywords
- dexmedetomidine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigators were unable to implement a MRI compatible EEG for use in human subjects (equipment and technical issues).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Nov 2018 (actual)
- 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 primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal.
Detailed description
The primary goal is to quantify cerebrospinal fluid (CSF) volume, diffusion characteristics and mechanical properties of brain tissue at two states of arousal:
- Resting, awake state
- During sleep with low-dose intravenous infusion of dexmedetomidine (titrated to a Bispectral index (BIS) of 60-70)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a preliminary interventional trial in which participants will serve as their own controls.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine induced sleep patients | Experimental | Drug: DexmedetomidineAll subjects will be measured for CSF volume, diffusion parameters and mechanical 'stiffness' of the brain during wakefulness and during sleep-induced with dexmedetomidine (DEXM). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Males or females between 18 and 40 years of age. Determined to be American Society of Anesthesiologist (ASA) 1 subjects.
- Ability to provide written informed consent.
Key exclusion criteria (17 listed)
- Subjects with potential difficult airway as determined by the anesthesiologist
- History of or family history of difficulty with anesthesia or sedation procedures
- Known intolerance to dexmedetomidine
- Body mass index >30
- Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or abnormal sleeping patterns (including but not limited to those who use a Continuous positive Airway Pressure (C-PAP) machine, sleeping during the day, using medication to fall asleep, subjects reporting snoring as determined by self- report using Snoring, Tiredness, Observed apnea, Blood pressure, Body mass index, Age, Neck circumference and Gender (STOP-BANG) questionnaire (i) for undiagnosed OSA (3 or more 'yes' answers will exclude) and/or medical history;
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 |
|---|---|---|
| DexmedetomidineAlso: DEXMThe standard dosing of 1mcg/kg will be implemented over 10 minutes followed by a maintenance infusion of 0.2-1.0 titrated to a the target BIS (60-70) during the 20 minutes prior to MRI. | Drug | Dexmedetomidine induced sleep patients |
Primary outcome
CSF volume increase by 10%
Time frame: 2 hours 30 minutes
We hypothesize that CSF volume (as measured by T1 relaxation) will expand by 10% with DEXM- induced sleep compared to wakefulness. The increase in CSF volume during DEXM-induced sleep occurs because DEXM lowers central norepinephrine tone and sleep causes an increase in the interstitial fluid (ISF) volume (cell volume shrinks). MRI will take place 30 minutes after dexmedetomidine infusion.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
Helene Benveniste, MD, PhD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexmedetomidine in people with Cerebrospinal Fluid Pressure Increased, run by Yale University.
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 2 inclusion and 17 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: withdrawn, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
CSF volume increase by 10% (time frame: 2 hours 30 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 31 May 2022.