McDESPOT: Myelin Imaging Changes In Patients With Neurosurgical Diseases

Sponsor
Memorial Healthcare System (Other)
Overall Status
Terminated
CT.gov ID
NCT03698838
Collaborator
(none)
20
1
17.1
1.2

Study Details

Study Description

Brief Summary

Investigate myelin alterations in patients with neurosurgical diseases

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

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 :
Feb 12, 2019
Actual Primary Completion Date :
Jul 15, 2020
Actual Study Completion Date :
Jul 15, 2020

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Myelin Alterations Read on MRI sequence [10 minutes]

    Investigate myelin alterations in patients with neurosurgical diseases with McDESPOT sequence on MRI scanner for T1 and T 2 scans.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Healthcare System Hollywood Florida United States 33021

Sponsors and Collaborators

  • Memorial Healthcare System

Investigators

  • Principal Investigator: Heather Spader, MD, Memorial Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Memorial Healthcare System
ClinicalTrials.gov Identifier:
NCT03698838
Other Study ID Numbers:
  • McDESPOT
First Posted:
Oct 9, 2018
Last Update Posted:
Sep 2, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:

Study Results

No Results Posted as of Sep 2, 2020