Chronic PainBODMEGNCT03232723
Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG
A study testing Whole-cortex MEG System (with optional EEG) in people with Chronic Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the effectiveness of the Magnetoencephalography (MEG) instrument to record electrical activity from parts of the body other than the brain. This study will examine if electrical activity from parts of the body, other than the brain, can be imaged by the MEG instrument. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Whole-cortex MEG System (with optional EEG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 7 Sep 2017
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults who are willing and able to provide informed consent.
Who cannot join
- Subjects with characteristics incompatible with MEG recordings as listed on the MEG Safety checklist (Appendix A),
- Involuntary, uncontrolled tremor,
- chronic pain.
- pregnant women (based on self-report).
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The primary purpose of this study is to determine the effectiveness of the Magnetoencephalography (MEG) instrument to record electrical activity from parts of the body other than the brain. This study will examine if electrical activity from parts of the body, other than the brain, can be imaged by the MEG instrument. Finding will contribute to studies of pain, since abnormal electrical activity in skeletal muscle is the basis of pain, which can be severe, yet there is no non-invasive way to image this abnormal activity. This is particularly relevant to deep muscle pain and back pain.
- Conditions
- Chronic Pain
- Being tested
- Whole-cortex MEG System (with optional EEG)
- Keywords
- Magnetoencephalography, Whole-cortex MEG System (with optional EEG)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-cortex MEG System (with optional EEG)Diagnostic test
"Whole-Cortex MEG System" non- invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The location may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain.
| Study group | Role | What they receive |
|---|---|---|
| MEG Recording | Other | Magnetic fields will be recorded using a 275-channel whole-head MEG system Receives: Diagnostic Test: Whole-cortex MEG System (with optional EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of optimal position to obtain safe and effective imaging of structures other than the brain.
- Hand position 1 relaxed
- Hand position 1 muscles active
- Hand position 2 relaxed
- Hand position 2 muscles active
- Neck and Jaw, relaxed
- Neck and Jaw, tensed
- Upper torso relaxed
- Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Measured: 2 Weeks
Evoked activity to obtain safe and effective imaging of structures other than the brain
- Hand position 1 relaxed
- Hand position 1 muscles active
- Hand position 2 relaxed
- Hand position 2 muscles active
- Neck and Jaw, relaxed
- Neck and Jaw, tensed
- Upper torso relaxed
- Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Measured: 2 Weeks
Secondary outcomes (2)
Dominant frequency of non-brain electrical activity in healthy adults.
- Hand position 1 relaxed
- Hand position 1 muscles active
- Hand position 2 relaxed
- Hand position 2 muscles active
- Neck and Jaw, relaxed
- Neck and Jaw, tensed
- Upper torso relaxed
- Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Measured: 2 Weeks
Location of non-brain of activity in healthy adults.
- Hand position 1 relaxed
- Hand position 1 muscles active
- Hand position 2 relaxed
- Hand position 2 muscles active
- Neck and Jaw, relaxed
- Neck and Jaw, tensed
- Upper torso relaxed
- Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
- Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Aug 2017
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodolfo Llinas, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232723
- Sponsor's protocol ID
- 17-00684
- Acronym
- BODMEG
- Status last verified
- Jun 2019
- First submitted
- 25 Jul 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG
- ClinicalTrials.gov ID
- NCT03232723
- Acronym / sponsor ID
- BODMEG / 17-00684
- Conditions
- Chronic Pain
- Keywords
- Magnetoencephalography, Whole-cortex MEG System (with optional EEG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 28 Jul 2017 (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 primary purpose of this study is to determine the effectiveness of the Magnetoencephalography (MEG) instrument to record electrical activity from parts of the body other than the brain. This study will examine if electrical activity from parts of the body, other than the brain, can be imaged by the MEG instrument. Finding will contribute to studies of pain, since abnormal electrical activity in skeletal muscle is the basis of pain, which can be severe, yet there is no non-invasive way to image this abnormal activity. This is particularly relevant to deep muscle pain and back pain.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEG Recording | Other | Diagnostic Test: Whole-cortex MEG System (with optional EEG)Magnetic fields will be recorded using a 275-channel whole-head MEG system |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults who are willing and able to provide informed consent.
Key exclusion criteria (4 listed)
- Subjects with characteristics incompatible with MEG recordings as listed on the MEG Safety checklist (Appendix A),
- Involuntary, uncontrolled tremor,
- chronic pain.
- pregnant women (based on self-report).
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 |
|---|---|---|
| Whole-cortex MEG System (with optional EEG)"Whole-Cortex MEG System" non- invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The location may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain. | Diagnostic test | MEG Recording |
Primary outcome
Determination of optimal position to obtain safe and effective imaging of structures other than the brain.
Time frame: 2 Weeks
* Hand position 1 relaxed * Hand position 1 muscles active * Hand position 2 relaxed * Hand position 2 muscles active * Neck and Jaw, relaxed * Neck and Jaw, tensed * Upper torso relaxed * Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.) * Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.) * Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.) * Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
Evoked activity to obtain safe and effective imaging of structures other than the brain
Time frame: 2 Weeks
* Hand position 1 relaxed * Hand position 1 muscles active * Hand position 2 relaxed * Hand position 2 muscles active * Neck and Jaw, relaxed * Neck and Jaw, tensed * Upper torso relaxed * Area of interest 1 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.) * Area of interest 1 tensed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.) * Area of interest 2 relaxed(areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.) * Area of interest 2 tensed (areas are not specific for Runs 9-11. (Possible areas are groups of muscles in the back and limbs.)
2 secondary outcomes
Dominant frequency of non-brain electrical activity in healthy adults.
Time frame: 2 Weeks
Location of non-brain of activity in healthy adults.
Time frame: 2 Weeks
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 5 Jun 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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.
Rodolfo Llinas, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-cortex MEG System (with optional EEG) in people with Chronic Pain, run by NYU Langone Health 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 4 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 5 Jun 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?
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?
Determination of optimal position to obtain safe and effective imaging of structures other than the brain. (time frame: 2 Weeks). The study lists 2 primary outcomes in all. 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 5 Jun 2019.