Clinical trial NCT03698838: Myelin Imaging Changes In Patients With Neurosurgical Diseases
Official title: A Pilot, Prospective Study of Myelin Imaging Changes in Patients With Neurosurgical Diseases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hydrocephalus in Children
Epilepsy
Craniosynostoses
Traumatic Brain Injury
Lead sponsor: Memorial Healthcare System
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 20
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Myelin Alterations Read on MRI sequence
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
Study officials:
affiliation: Memorial Healthcare System
name: Heather Spader, MD
role: PRINCIPAL_INVESTIGATOR
References: