Peripheral Nerve Stimulation in MRINEUROMANNCT04674787
Uncertainty Analysis of Computational Model to Simulate Neurostimulation Caused by Gradient Fields in MRI
A study testing Peripheral nerve stimulation provocation study in people with Peripheral Nerve Stimulation in MRI and Electric Stimulation, run by Bryn Lloyd at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Stimulation in MRI, Electric Stimulation
- What is being tested?
- Peripheral nerve stimulation provocation study
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2021to 20 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adult volunteers (six female and six male)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- Peripheral nerve stimulation provocation study
- Keywords
- MRI gradient coil, peripheral nerve stimulation, Time varying magnetic fields
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve stimulation provocation studyOther
Study which measures stimulation thresholds in volunteers induced by low frequency electromagnetic gradients used in MRI scanners.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure PNS stimulation thresholds
The primary objective is to measure PNS stimulation thresholds in order to quantify the modeling uncertainty and reliability.
Measured: The experimental procedure will be conducted during a single visit of approx. 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Mar 2021
- Primary completion20 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve Stimulation in MRIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bryn Lloyd
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Biomedical Engineering, Swiss Federal Institute of Technology (ETH Zurich)
- Responsible party
- Sponsor-investigator, Bryn Lloyd, The Foundation for Research on Information Technologies in Society (IT'IS), Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674787
- Sponsor's protocol ID
- NEUROMAN
- Acronym
- NEUROMAN
- Status last verified
- May 2021
- First submitted
- 14 Dec 2020
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncertainty Analysis of Computational Model to Simulate Neurostimulation Caused by Gradient Fields in MRI
- ClinicalTrials.gov ID
- NCT04674787
- Acronym / sponsor ID
- NEUROMAN / NEUROMAN
- Keywords
- MRI gradient coil, peripheral nerve stimulation, Time varying magnetic fields
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bryn LloydUniversity, hospital or other
- Collaborators
- Institute for Biomedical Engineering, Swiss Federal Institute of Technology (ETH Zurich)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adult volunteers (six female and six male)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral nerve stimulation provocation studyStudy which measures stimulation thresholds in volunteers induced by low frequency electromagnetic gradients used in MRI scanners. | Other | – |
Primary outcome
Measure PNS stimulation thresholds
Time frame: The experimental procedure will be conducted during a single visit of approx. 90 minutes.
The primary objective is to measure PNS stimulation thresholds in order to quantify the modeling uncertainty and reliability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral nerve stimulation provocation study in people with Peripheral Nerve Stimulation in MRI and Electric Stimulation, run by Bryn Lloyd at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure PNS stimulation thresholds (time frame: The experimental procedure will be conducted during a single visit of approx. 90 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.