Myelin Imaging Changes In Patients With Neurosurgical Diseases

NCT03698838 | Terminated FDA Device

• 1 other identifier: McDESPOT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Investigate myelin alterations in patients with neurosurgical diseases

Conditions

Hydrocephalus in Children; Epilepsy; Craniosynostoses; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Control Model

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

Interventions

McDESPOT DEVICE

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

McDESPOT Study Group

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \. Unable to tolerate an extra 10 minutes of MRI scan

Sponsors & Collaborators

• Memorial Healthcare System: lead

Study Sites (1)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

MeSH Terms

Conditions

Epilepsy; Craniosynostoses; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Heather Spader, MD

  Memorial Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: February 12, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)