Sensory DisordersNCT01632800
Sensory Effects of Rapidly-Changing Magnetic Fields
A study testing High pulsed magnetic fields in people with Sensory Disorders, run by Weinberg Medical Physics LLC at 1 site in United States.
Trial summary
This study is being conducted to improve magnetic resonance imaging (MRI) scans by reducing the time required for imaging. Experience has shown that unpleasant side-effects from magnetic pulses used in MRI (for example, tingling or tapping sensations) can be reduced when the magnetic pulses are shortened. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensory Disorders
- What is being tested?
- High pulsed magnetic fields
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults over 18, capable of informed consent
Who cannot join
- History of arrhythmia. Has implanted pacemaker or defibrillator, right wrist-to-sternum distance of less than 60 centimeters, visible tattoos of the right hand or wrist, or with any metallic objects that cannot be removed from the right hand or wrist. Irregular or imperceptible pulse. Heart rate less than 50 beats per minute or more than 100 per minute, resting respiratory rate greater than 25 per minute, diastolic blood pressure less than 50. Solid meal ingested within 2 hours prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to improve magnetic resonance imaging (MRI) scans by reducing the time required for imaging. Experience has shown that unpleasant side-effects from magnetic pulses used in MRI (for example, tingling or tapping sensations) can be reduced when the magnetic pulses are shortened. In this study, we will explore whether this effect holds true when very short magnetic pulses are applied.
Read the detailed description
See above
- Conditions
- Sensory Disorders
- Being tested
- High pulsed magnetic fields
- Keywords
- Magnetic fields discomfort
- Medical subject headings
- Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High pulsed magnetic fieldsDevice
Also called Pulser is custom built by Applied Pulsed Power, Ithaca NY
Magnetic fields will escalate in strength
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | Each subjects will undergo escalating exposure to magnetic field Receives: Device: High pulsed magnetic fields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Discomfort Under Applied Pulsed Magnetic Fields
Pulsed magnetic fields will be applied a total of forty-eight times to the right hand of each subject. After each time the magnet coil is pulsed, the subject will be asked if he or she notices any sensation (for example, tingling or tapping). Subjects will be asked to rate the sensation from 0 to 4, where 0 means no sensation, 1 means barely-noticeable sensation, 2 means easily noticeable sensation, 3 means unpleasant sensation, and 4 means very unpleasant sensation.
Measured: Bioeffects will be assessed within the five-minute application of each pulse sequence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sensory DisordersStudies 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weinberg Medical Physics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Stanley Fricke, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632800
- Sponsor's protocol ID
- WMP 5.0
- Other IDs
- R42HL086294-04, 9R42NS073289-06
- Status last verified
- Oct 2019
- First submitted
- 17 Mar 2010
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Effects of Rapidly-Changing Magnetic Fields
- ClinicalTrials.gov ID
- NCT01632800
- Acronym / sponsor ID
- WMP 5.0
- Conditions
- Sensory Disorders
- Keywords
- Magnetic fields discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Weinberg Medical Physics LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Posted 15 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to improve magnetic resonance imaging (MRI) scans by reducing the time required for imaging. Experience has shown that unpleasant side-effects from magnetic pulses used in MRI (for example, tingling or tapping sensations) can be reduced when the magnetic pulses are shortened. In this study, we will explore whether this effect holds true when very short magnetic pulses are applied.
Detailed description
See above
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Device: High pulsed magnetic fieldsEach subjects will undergo escalating exposure to magnetic field |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over 18, capable of informed consent
Key exclusion criteria (1 listed)
- History of arrhythmia. Has implanted pacemaker or defibrillator, right wrist-to-sternum distance of less than 60 centimeters, visible tattoos of the right hand or wrist, or with any metallic objects that cannot be removed from the right hand or wrist. Irregular or imperceptible pulse. Heart rate less than 50 beats per minute or more than 100 per minute, resting respiratory rate greater than 25 per minute, diastolic blood pressure less than 50. Solid meal ingested within 2 hours prior to the study.
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 |
|---|---|---|
| High pulsed magnetic fieldsAlso: Pulser is custom built by Applied Pulsed Power, Ithaca NYMagnetic fields will escalate in strength | Device | Single arm study |
Primary outcome
Degree of Discomfort Under Applied Pulsed Magnetic Fields
Time frame: Bioeffects will be assessed within the five-minute application of each pulse sequence
Pulsed magnetic fields will be applied a total of forty-eight times to the right hand of each subject. After each time the magnet coil is pulsed, the subject will be asked if he or she notices any sensation (for example, tingling or tapping). Subjects will be asked to rate the sensation from 0 to 4, where 0 means no sensation, 1 means barely-noticeable sensation, 2 means easily noticeable sensation, 3 means unpleasant sensation, and 4 means very unpleasant sensation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stanley Fricke, PhD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High pulsed magnetic fields in people with Sensory Disorders, run by Weinberg Medical Physics LLC at 1 site in United States.
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 1 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 8 Oct 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Degree of Discomfort Under Applied Pulsed Magnetic Fields (time frame: Bioeffects will be assessed within the five-minute application of each pulse sequence). 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 8 Oct 2019.