Myelin Imaging Changes In Patients With Neurosurgical Diseases

Terminated

• Conditions: Craniosynostoses; Hydrocephalus in Children; Traumatic Brain Injury; Epilepsy
• Interventions: Device: McDESPOT

• Registration Number: NCT03698838
• Lead Sponsor: Memorial Healthcare System

Brief Summary

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 Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Study Start: 2019-02-12
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
McDESPOT Study Group	McDESPOT	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Memorial Healthcare System; 🇺🇸 Hollywood, Florida, United States