Myelin Imaging Changes In Patients With Neurosurgical Diseases

Epilepsy Clinical Trial

— McDESPOT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03698838
• Other study ID #: McDESPOT
• Status: Terminated
• Start date: February 12, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: August 2020
• Source: Memorial Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigate myelin alterations in patients with neurosurgical diseases

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Craniosynostoses
• Epilepsy
• Hydrocephalus
• Hydrocephalus in Children
• Traumatic Brain Injury

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Healthcare System	Hollywood	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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