Clinical trial NCT04674787: Uncertainty Analysis of Computational Model to Simulate Neurostimulation Caused by Gradient Fields in MRI
Official title: Uncertainty Analysis of Computational Model to Simulate Neurostimulation Caused by Gradient Fields in MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Nerve Stimulation in MRI
Electric Stimulation
Keywords: MRI gradient coil
peripheral nerve stimulation
Time varying magnetic fields
Lead sponsor: The Foundation for Research on Information Technologies in Society (IT'IS), Switzerland
Sponsor class: OTHER
Collaborators: name: Institute for Biomedical Engineering, Swiss Federal Institute of Technology (ETH Zurich)
First posted: 2020-12-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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, i.e. 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, e.g. tingling, twitching or poking. PNS is not considered a health concern. The radio-frequency (RF) field will remain switched off, i.e. there is no risk of heating (the scanner will not acquire images in this mode).

Eligibility criteria: Inclusion Criteria:

* healthy adult volunteers (six female and six male)

Exclusion Criteria:

* pregnant woman
* metallic implants or a history of neurological or cardiovascular diseases
* children and persons who are not able to follow the instructions will be excluded, due to a higher risk and lack of direct benefits from participation

Primary outcomes:
measure: Measure PNS stimulation thresholds
timeFrame: The experimental procedure will be conducted during a single visit of approx. 90 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: IT'IS Foundation
state: ZH
Study officials:
References: