Hydrocephalus in ChildrenMcDESPOTNCT03698838
Myelin Imaging Changes In Patients With Neurosurgical Diseases
An observational study of Hydrocephalus in Children and Epilepsy, run by Memorial Healthcare System at 1 site in United States.
Trial summary
Investigate myelin alterations in patients with neurosurgical diseases Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Hydrocephalus in Children, Epilepsy, Craniosynostoses
- What is being tested?
- McDESPOT
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 15 Jul 2020
- Phase
- Observational
- 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 Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 0-19 who have an MRI ordered clinically and have one of the following conditions: epilepsy, hydrocephalus, craniosynostosis or mild traumatic brain injury. Epilepsy, hydrocephalus and craniosynostosis patients will be both newly diagnosed and chronic. MTBI patients will be acute and chronic and defined as a glascow coma score (GCS) of 13-15.
Who may be able to join
- Patient age range: 0-19
- Patients who have an MRI ordered clinically and have one of the following conditions: epilepsy, hydrocephalus, craniosynostosis or mild traumatic brain injury. Epilepsy, hydrocephalus and craniosynostosis patients will be both newly diagnosed and chronic. MTBI patients will be acute and chronic and defined as a glascow coma score (GCS) of 13-15.
- Patients or their proxy should be capable of giving informed consent
Who cannot join
- 1. Unable to tolerate an extra 10 minutes of MRI scan
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Healthcare System
Hollywood, Florida, 33021
About this study
Official title: A Pilot, Prospective Study of Myelin Imaging Changes in Patients With Neurosurgical Diseases
Investigate myelin alterations in patients with neurosurgical diseases
Read the detailed description
While a number of advanced imaging techniques, notably magnetization transfer, diffusion tensor and quantitative T1 and T2 imaging (MTI, DTI, qT1 and qT2, respectively), have been used previously to study white matter in neurosurgical diseases, these methods provide only indirect, non-specific information related to myelin content. For example, these modalities can tell when there is swelling that is affecting the movement of water, which may be indicative of a process that would affect myelin, but they cannot tell us specific information about the amount of myelin surrounding a nerve.
The investigators propose using a MRI sequence, mcDESPOT (multicomponent driven equilibrium potential of T1 and T2) that utilizes a computer model that takes T1 and T2 sequences and derives a quantitative value for the myelin content in the myelin sheath.
In the present program, the investigators propose adding the mcDESPOT sequence to the MRI scanner in accordance with the MRI manufacturer's technical requirements. When this sequence is added, the normal sequences are done first and mcDESPOT is done last. Although the sequences obtained for mcDESPOT are sequences used in clinical practice, the flip-angles are changed so that they cannot be read like a traditional image. Rather, the data have to be post-processed by a computer in order to be able to derive myelin information.
McDESPOT is a 10 minute sequence that can be added to any MRI scanner. It is a obtained from standard T1 and T2 sequences.
- Being tested
- McDESPOT
- Medical subject headings
- Epilepsy, Craniosynostoses, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McDESPOTDevice
MRI sequence, mcDESPOT (multicomponent driven equilibrium potential of T1 and T2) that utilizes a computer model that takes T1 and T2 sequences and derives a quantitative value for the myelin content in the myelin sheath
| Study group | Role | What they receive |
|---|---|---|
| McDESPOT Study Group | Patients aged 0-19 who have an MRI ordered clinically and have one of the following conditions: epilepsy, hydrocephalus, craniosynostosis or mild traumatic brain injury. Epilepsy, hydrocephalus and craniosynostosis patients will be both newly diagnosed and chronic. MTBI patients will be acute and chronic and defined as a glascow coma score (GCS) of 13-15.These patients will have a 10 minute MRI sequence (McDESPOT) added to their standard of care T1 and T2 scans. Receives: Device: McDESPOT | |
| Control Model | Control model derived from a linear mixed-effects model (Spader et al 2013) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myelin Alterations Read on MRI sequence
Investigate myelin alterations in patients with neurosurgical diseases with McDESPOT sequence on MRI scanner for T1 and T 2 scans.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start12 Feb 2019
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Why it stopped: Principal Investigator left Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrocephalus in ChildrenStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Spader, MD, Principal investigator, Memorial Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698838
- Sponsor's protocol ID
- McDESPOT
- Acronym
- McDESPOT
- Status last verified
- Aug 2020
- First submitted
- 4 Oct 2018
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Prospective Study of Myelin Imaging Changes in Patients With Neurosurgical Diseases
- ClinicalTrials.gov ID
- NCT03698838
- Acronym / sponsor ID
- McDESPOT / McDESPOT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator left Institution
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Healthcare SystemUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 9 Oct 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.
Investigate myelin alterations in patients with neurosurgical diseases
Detailed description
While a number of advanced imaging techniques, notably magnetization transfer, diffusion tensor and quantitative T1 and T2 imaging (MTI, DTI, qT1 and qT2, respectively), have been used previously to study white matter in neurosurgical diseases, these methods provide only indirect, non-specific information related to myelin content. For example, these modalities can tell when there is swelling that is affecting the movement of water, which may be indicative of a process that would affect myelin, but they cannot tell us specific information about the amount of myelin surrounding a nerve.
The investigators propose using a MRI sequence, mcDESPOT (multicomponent driven equilibrium potential of T1 and T2) that utilizes a computer model that takes T1 and T2 sequences and derives a quantitative value for the myelin content in the myelin sheath.
In the present program, the investigators propose adding the mcDESPOT sequence to the MRI scanner in accordance with the MRI manufacturer's technical requirements. When this sequence is added, the normal sequences are done first and mcDESPOT is done last. Although the sequences obtained for mcDESPOT are sequences used in clinical practice, the flip-angles are changed so that they cannot be read like a traditional image. Rather, the data have to be post-processed by a computer in order to be able to derive myelin information.
McDESPOT is a 10 minute sequence that can be added to any MRI scanner. It is a obtained from standard T1 and T2 sequences.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McDESPOT Study Group | – | Device: McDESPOTPatients aged 0-19 who have an MRI ordered clinically and have one of the following conditions: epilepsy, hydrocephalus, craniosynostosis or mild traumatic brain injury. Epilepsy, hydrocephalus and craniosynostosis patients will be both newly diagnosed and chronic. MTBI patients will be acute and chronic and defined as a glascow coma score (GCS) of 13-15.These patients will have a 10 minute MRI sequence (McDESPOT) added to their standard of care T1 and T2 scans. |
| Control Model | – | –Control model derived from a linear mixed-effects model (Spader et al 2013) |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 0-19 who have an MRI ordered clinically and have one of the following conditions: epilepsy, hydrocephalus, craniosynostosis or mild traumatic brain injury. Epilepsy, hydrocephalus and craniosynostosis patients will be both newly diagnosed and chronic. MTBI patients will be acute and chronic and defined as a glascow coma score (GCS) of 13-15.
Key inclusion criteria (3 listed)
- Patient age range: 0-19
- Patients who have an MRI ordered clinically and have one of the following conditions: epilepsy, hydrocephalus, craniosynostosis or mild traumatic brain injury. Epilepsy, hydrocephalus and craniosynostosis patients will be both newly diagnosed and chronic. MTBI patients will be acute and chronic and defined as a glascow coma score (GCS) of 13-15.
- Patients or their proxy should be capable of giving informed consent
Key exclusion criteria (1 listed)
- 1. Unable to tolerate an extra 10 minutes of MRI scan
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 |
|---|---|---|
| McDESPOTMRI sequence, mcDESPOT (multicomponent driven equilibrium potential of T1 and T2) that utilizes a computer model that takes T1 and T2 sequences and derives a quantitative value for the myelin content in the myelin sheath | Device | McDESPOT Study Group |
Primary outcome
Myelin Alterations Read on MRI sequence
Time frame: 10 minutes
Investigate myelin alterations in patients with neurosurgical diseases with McDESPOT sequence on MRI scanner for T1 and T 2 scans.
Results and safety
The study was stopped early (reason given: Principal Investigator left Institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- 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.
Heather Spader, MD principal investigator
Memorial Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus in Children and Epilepsy, run by Memorial Healthcare System 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 2 Sep 2020. 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 was stopped early (reason given: Principal Investigator left Institution). Results are not available in the source record.
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?
Myelin Alterations Read on MRI sequence (time frame: 10 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 2 Sep 2020.