Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myelin Imaging Changes In Patients With Neurosurgical Diseases (McDESPOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03698838
Recruitment Status : Terminated (Principal Investigator left Institution)
First Posted : October 9, 2018
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Healthcare System

Brief Summary:
Investigate myelin alterations in patients with neurosurgical diseases

Condition or disease Intervention/treatment
Hydrocephalus in Children Epilepsy Craniosynostoses Traumatic Brain Injury Device: McDESPOT

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Pilot, Prospective Study of Myelin Imaging Changes in Patients With Neurosurgical Diseases
Actual Study Start Date : February 12, 2019
Actual Primary Completion Date : July 15, 2020
Actual Study Completion Date : July 15, 2020


Group/Cohort Intervention/treatment
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.
Device: McDESPOT
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

Control Model
Control model derived from a linear mixed-effects model (Spader et al 2013)



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Patient age range: 0-19
  2. 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.
  3. Patients or their proxy should be capable of giving informed consent

Exclusion Criteria:

1. Unable to tolerate an extra 10 minutes of MRI scan


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698838


Locations
Layout table for location information
United States, Florida
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Sponsors and Collaborators
Memorial Healthcare System
Investigators
Layout table for investigator information
Principal Investigator: Heather Spader, MD Memorial Healthcare System
Layout table for additonal information
Responsible Party: Memorial Healthcare System
ClinicalTrials.gov Identifier: NCT03698838    
Other Study ID Numbers: McDESPOT
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Craniosynostoses
Brain Injuries
Brain Injuries, Traumatic
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities