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

Electric Stimulation Clinical Trial

— NEUROMAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674787
• Other study ID #: NEUROMAN
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 20, 2021

Study information

• Verified date: May 2021
• Source: The Foundation for Research on Information Technologies in Society (IT'IS), Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Electric Stimulation
• Peripheral Nerve Stimulation in MRI

Intervention

Other:
• Peripheral nerve stimulation provocation study
Study which measures stimulation thresholds in volunteers induced by low frequency electromagnetic gradients used in MRI scanners.

Locations

Country	Name	City	State
Switzerland	IT'IS Foundation	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
Bryn Lloyd	Institute for Biomedical Engineering, Swiss Federal Institute of Technology (ETH Zurich)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.