Myelin Imaging Changes In Patients With Neurosurgical Diseases (McDESPOT)

A Pilot, Prospective Study of Myelin Imaging Changes in Patients With Neurosurgical Diseases

Investigate myelin alterations in patients with neurosurgical diseases

Study Overview

• Status: Terminated
• Conditions: Epilepsy; Traumatic Brain Injury; Hydrocephalus in Children; Craniosynostoses
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes

Collaborators and Investigators

• Sponsor: Memorial Healthcare System

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2019
• Primary Completion (ACTUAL): July 15, 2020
• Study Completion (ACTUAL): July 15, 2020

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Congenital Abnormalities; Musculoskeletal Diseases; Craniocerebral Trauma; Trauma, Nervous System; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Dysostoses; Synostosis; Brain Injuries; Brain Injuries, Traumatic; Hydrocephalus; Craniosynostoses
• Other Study ID Numbers: McDESPOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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