Myelin Imaging Changes In Patients With Neurosurgical Diseases (McDESPOT)
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|ClinicalTrials.gov Identifier: NCT03698838|
Recruitment Status : Terminated (Principal Investigator left Institution)
First Posted : October 9, 2018
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment|
|Hydrocephalus in Children Epilepsy Craniosynostoses Traumatic Brain Injury||Device: McDESPOT|
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|
|Actual Enrollment :||20 participants|
|Official Title:||A Pilot, Prospective Study of Myelin Imaging Changes in Patients With Neurosurgical Diseases|
|Actual Study Start Date :||February 12, 2019|
|Actual Primary Completion Date :||July 15, 2020|
|Actual Study Completion Date :||July 15, 2020|
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.
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 derived from a linear mixed-effects model (Spader et al 2013)
- Myelin Alterations Read on MRI sequence [ Time Frame: 10 minutes ]Investigate myelin alterations in patients with neurosurgical diseases with McDESPOT sequence on MRI scanner for T1 and T 2 scans.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698838
|United States, Florida|
|Memorial Healthcare System|
|Hollywood, Florida, United States, 33021|
|Principal Investigator:||Heather Spader, MD||Memorial Healthcare System|