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

NCT04674787 | Completed DMC

• 1 other identifier: NEUROMAN
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nerve Stimulation in MRI; Electric Stimulation

Keywords

MRI gradient coil; peripheral nerve stimulation; Time varying magnetic fields

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Peripheral nerve stimulation provocation study OTHER

Study which measures stimulation thresholds in volunteers induced by low frequency electromagnetic gradients used in MRI scanners.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adult volunteers (six female and six male)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

IT'IS Foundation

Zurich, Canton of Zurich, 8092, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project Leader

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: March 1, 2021
• Primary Completion: March 20, 2021
• Study Completion: March 20, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of our findings in a peer reviewed journal
• Access Criteria: Openly available to interested parties.

Locations

CH (1)