Uncertainty Analysis of Computational Model to Simulate Neurostimulation Caused by Gradient Fields in MRI (NEUROMAN)

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.

Study Overview

• Status: Completed
• Conditions: Electric Stimulation; Peripheral Nerve Stimulation in MRI
• Intervention / Treatment: Other: Peripheral nerve stimulation provocation study

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).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8092
      • IT'IS Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure PNS stimulation thresholds	The primary objective is to measure PNS stimulation thresholds in order to quantify the modeling uncertainty and reliability.	The experimental procedure will be conducted during a single visit of approx. 90 minutes.

Collaborators and Investigators

• Sponsor: Bryn Lloyd
• Collaborators: Institute for Biomedical Engineering, Swiss Federal Institute of Technology (ETH Zurich)

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): March 20, 2021
• Study Completion (ACTUAL): March 20, 2021

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (ACTUAL): December 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: peripheral nerve stimulation; MRI gradient coil; Time varying magnetic fields
• Other Study ID Numbers: NEUROMAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Stimulation thresholds and stimulation locations will be recorded for each stimulation configuration (81 measurements with different subject position, posture, slew rates).

This stimulation measurement data will be shared after publication of our findings in anonymized form to allow other researchers to validate their models with the data.

• IPD Sharing Time Frame: After publication of our findings in a peer reviewed journal
• IPD Sharing Access Criteria: Openly available to interested parties.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No