Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04674787
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2020-12-14
Brief Title:
Uncertainty Analysis of Computational Model to Simulate Neurostimulation Caused by Gradient Fields in MRI
Sponsor:
Bryn Lloyd
Organization:
The Foundation for Research on Information Technologies in Society ITIS Switzerland
Study Overview
Official Title:
Uncertainty Analysis of Computational Model to Simulate Neurostimulation Caused by Gradient Fields in MRI
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUROMAN
Brief Summary:
The aim of this research project is to quantify the uncertainty of current state-of-the art anatomical phantoms and computational models for predicting neurostimulation induced by time-varying magnetic fields so-called gradient fields within the context of magnetic resonance imaging MRI scanners For this purpose stimulation thresholds will be measured in a volunteer study The measurements will provide valuable data for the development and validation of future models
Detailed Description:
The study does not investigate any health related interventions neither a therapy nor medical device The study aims to provoke peripheral nerve stimulation from time varying magnetic so-called gradient fields in volunteers in order to measure gradient threshold levels in different configurations different gradient coil units different positions and postures The experiments will provide new data regarding the interaction of gradient fields and function of the peripheral nervous system These measurements are of general interest to quantify associated modeling uncertainties and validate current or future computational modeling techniques
The experiments will use an MR scanner to generate the gradient fields used to induce stimulation In normal mode the maximum gradient field allowed by the manufacturer may lead to peripheral nerve stimulation in approximately 50 of subjects However depending on the position and posture it may induce PNS in even fewer than 50 of subjects Therefore for the purpose of measuring stimulation thresholds it is necessary to operate the gradient units in experimental mode with respect to the gradient field as described in IEC 60601-2-33 ie the gradient limits set by the manufacturer will be disabled As described in the standard the gradient field will be increased slowly from non-stimulating levels until the volunteer perceives first stimulation sensations at which point the gradient field will be stopped This protocol does not lead to an increased risk of cardiac muscle stimulation compared to the normal mode but only an increased likelihood of PNS with non-painful sensations in the skin eg tingling twitching or poking PNS is not considered a health concern The radio-frequency RF field will remain switched off ie there is no risk of heating the scanner will not acquire images in this mode
The experiments will use an MR scanner to generate the gradient fields used to induce stimulation In normal mode the maximum gradient field allowed by the manufacturer may lead to peripheral nerve stimulation in approximately 50 of subjects However depending on the position and posture it may induce PNS in even fewer than 50 of subjects Therefore for the purpose of measuring stimulation thresholds it is necessary to operate the gradient units in experimental mode with respect to the gradient field as described in IEC 60601-2-33 ie the gradient limits set by the manufacturer will be disabled As described in the standard the gradient field will be increased slowly from non-stimulating levels until the volunteer perceives first stimulation sensations at which point the gradient field will be stopped This protocol does not lead to an increased risk of cardiac muscle stimulation compared to the normal mode but only an increased likelihood of PNS with non-painful sensations in the skin eg tingling twitching or poking PNS is not considered a health concern The radio-frequency RF field will remain switched off ie there is no risk of heating the scanner will not acquire images in this mode
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None