Glymphatic FlowEarly Phase 1NCT02768688
MRI of Glymphatic Clearance During Anesthetic Sedation
A Early Phase 1 study testing Brain connectivity and physiology and Dexmedetomidine in people with Glymphatic Flow, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5 healthy human subjects as visualized by diffusion tensor MRI. The study is designed to measure clinically established, safe imaging of DTI and cerebral blood flow at baseline, during a continuous intravenous infusion of… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Glymphatic Flow
- What is being tested?
- Brain connectivity and physiology and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2017
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Person aged 20-40 years old,
- American Society of Anesthesiologists Physical Status I or II (i.e., healthy),
- Body mass index ≤ 30 kg/m2,
- Easily visualized uvula,
- Not a current tobacco user
- No history of alcohol abuse/must abstain from alcohol use 24 hours prior to and 24 hours after participation.
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- Ability to sign informed consent.
- Able to pass standard MRI safety screening
- Must have a responsible adult available to transport subject home safely after end of experiment.
Who cannot join
- Healthy male or females less than 20 years of age or older than 40 years of age
- Any physical signs suggestive of difficult airway (mouth opening 3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck),
- History of obstructive sleep apnea,
- History of asthma
- Neuropsychiatric disorders,
- History of, or current use of psychotropic medications,
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- Current tobacco use or history of smoking in past month
- Alcohol use exceeding 2 drinks/day
- History of hypertension or current medication for blood pressure control,
- Cardiovascular disease or arrhythmias,
- Positive urine toxicology screen,
- History of gastroesophageal reflux disease,
- Pregnancy,
- Sleep disorders,
- History of postoperative nausea/vomiting or motion sickness,
- Inability to sign informed consent
- Contraindications for safely participating in MRI imaging study,
- Does not have a responsible adult available to provide transport from HUP MRI area to home.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Glymphatic Clearance During Anesthesia and Sleep: A Diffusion Tensor Imaging (DTI) Study in Humans
This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5 healthy human subjects as visualized by diffusion tensor MRI. The study is designed to measure clinically established, safe imaging of DTI and cerebral blood flow at baseline, during a continuous intravenous infusion of dexmedetomidine at doses designed to produce anesthesia-induced unconsciousness to simulate natural sleep, and again on return to wakefulness.
Read the detailed description
Objective:
The purpose of this study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI.
Study Design:
This study will take place at the University of Pennsylvania. Investigators plan to enroll approximately 30 healthy volunteers to generate pilot data for a larger grant submission.
Characteristics of the Study Population:
Subjects will be healthy males or females aged 20 to 40 years of age who will be recruited to participate in an MRI scan designed to measure clinically established, safe imaging of diffusion tensor imaging and cerebral blood flow at baseline, during a continuous intravenous infusion of dexmedetomidine at doses designed to produce anesthesia-induced unconsciousness to simulate natural sleep, and again on return to wakefulness. They must be able to pass the standard MRI safety assessment (e.g., no metallic metal clips or implants or any other contraindications to undergoing an MRI).
Design:
Upon successful completion of screening questionnaire, urine drug, and urine pregnancy subjects will be scheduled for an MRI. On the day of the study subjects will receive an intravenous catheter (IV) for study drug and fluids. Set one of MRI scans will be done with no dexmedetomidine. Set two of scans will be done when subject is anesthetized with dexmedetomidine with the goal depth of sedation will be moderate sedation. Set three of scans will be done when dexmedetomidine is stopped and wakefulness is achieved.
- Conditions
- Glymphatic Flow
- Being tested
- Brain connectivity and physiology, Dexmedetomidine
- Keywords
- Human Brain, Magnetic Resonance Imaging (MRI), Dexmedetomidine, Cerebral blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain connectivity and physiologyOther
MRI to measure glymphactic flow during simulated natural sleep and again on return to wakefulness.
DexmedetomidineDrug
Administering of 0.5-1.0 mcg/kg/hr of dexmedetomidine to ensure subject's loss of consciousness.
| Study group | Role | What they receive |
|---|---|---|
| Brain connectivity and physiology | Experimental | Dexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI. Receives: Other: Brain connectivity and physiology; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glymphatic clearance from the human brain
Assessment of the effect of dexmedetomidine anesthesia on glymphatic flow in subjects as visualized by diffusion tensor MRI.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJul 2014
- Primary completion9 Feb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glymphatic FlowStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max B Kelz, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768688
- Sponsor's protocol ID
- 819962
- Status last verified
- Jan 2018
- First submitted
- 5 Apr 2016
- Last updated
- 25 Jan 2018
- 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 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glymphatic Clearance During Anesthesia and Sleep: A Diffusion Tensor Imaging (DTI) Study in Humans
- ClinicalTrials.gov ID
- NCT02768688
- Acronym / sponsor ID
- 819962
- Conditions
- Glymphatic Flow
- Keywords
- Human Brain, Magnetic Resonance Imaging (MRI), Dexmedetomidine, Cerebral blood flow
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 May 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.
This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5 healthy human subjects as visualized by diffusion tensor MRI. The study is designed to measure clinically established, safe imaging of DTI and cerebral blood flow at baseline, during a continuous intravenous infusion of dexmedetomidine at doses designed to produce anesthesia-induced unconsciousness to simulate natural sleep, and again on return to wakefulness.
Detailed description
Objective:
The purpose of this study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI.
Study Design:
This study will take place at the University of Pennsylvania. Investigators plan to enroll approximately 30 healthy volunteers to generate pilot data for a larger grant submission.
Characteristics of the Study Population:
Subjects will be healthy males or females aged 20 to 40 years of age who will be recruited to participate in an MRI scan designed to measure clinically established, safe imaging of diffusion tensor imaging and cerebral blood flow at baseline, during a continuous intravenous infusion of dexmedetomidine at doses designed to produce anesthesia-induced unconsciousness to simulate natural sleep, and again on return to wakefulness. They must be able to pass the standard MRI safety assessment (e.g., no metallic metal clips or implants or any other contraindications to undergoing an MRI).
Design:
Upon successful completion of screening questionnaire, urine drug, and urine pregnancy subjects will be scheduled for an MRI. On the day of the study subjects will receive an intravenous catheter (IV) for study drug and fluids. Set one of MRI scans will be done with no dexmedetomidine. Set two of scans will be done when subject is anesthetized with dexmedetomidine with the goal depth of sedation will be moderate sedation. Set three of scans will be done when dexmedetomidine is stopped and wakefulness is achieved.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain connectivity and physiology | Experimental | Other: Brain connectivity and physiology, Drug: DexmedetomidineDexmedetomidine anesthesia on glymphatic flow in human subjects as visualized by diffusion tensor MRI. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Person aged 20-40 years old,
- American Society of Anesthesiologists Physical Status I or II (i.e., healthy),
- Body mass index ≤ 30 kg/m2,
- Easily visualized uvula,
- Not a current tobacco user
Key exclusion criteria (18 listed)
- Healthy male or females less than 20 years of age or older than 40 years of age
- Any physical signs suggestive of difficult airway (mouth opening 3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck),
- History of obstructive sleep apnea,
- History of asthma
- Neuropsychiatric disorders,
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 |
|---|---|---|
| Brain connectivity and physiologyMRI to measure glymphactic flow during simulated natural sleep and again on return to wakefulness. | Other | Brain connectivity and physiology |
| DexmedetomidineAdministering of 0.5-1.0 mcg/kg/hr of dexmedetomidine to ensure subject's loss of consciousness. | Drug | Brain connectivity and physiology |
Primary outcome
Glymphatic clearance from the human brain
Time frame: 2 hours
Assessment of the effect of dexmedetomidine anesthesia on glymphatic flow in subjects as visualized by diffusion tensor MRI.
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 25 Jan 2018.
- 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.
Max B Kelz, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Brain connectivity and physiology and Dexmedetomidine in people with Glymphatic Flow, run by University of Pennsylvania 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 9 inclusion and 18 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 25 Jan 2018. 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.
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 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?
Glymphatic clearance from the human brain (time frame: 2 hours). 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 25 Jan 2018.