Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG - Clinical Trial for Chronic Pain | NCT03232723

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Whole-cortex MEG System (with optional EEG)

About this trial

This is an interventional device feasibility trial for Chronic Pain focused on measuring Magnetoencephalography, Whole-cortex MEG System (with optional EEG)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adults who are willing and able to provide informed consent.

Exclusion Criteria:

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).

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MEG Recording

Arm Description

Magnetic fields will be recorded using a 275-channel whole-head MEG system

Outcomes

Primary Outcome Measures

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.)

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.)

Secondary Outcome Measures

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.)

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.)

Full Information

NCT ID

NCT03232723

First Posted

July 25, 2017

Last Updated

June 3, 2019

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT03232723

Brief Title

Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG

Acronym

BODMEG

Official Title

Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

September 7, 2017 (Actual)

Study Completion Date

September 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

Magnetoencephalography, Whole-cortex MEG System (with optional EEG)

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MEG Recording

Arm Type

Other

Arm Description

Magnetic fields will be recorded using a 275-channel whole-head MEG system

Intervention Type

Diagnostic Test

Intervention Name(s)

Whole-cortex MEG System (with optional EEG)

Intervention Description

"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.

Primary Outcome Measure Information:

Title

Determination of optimal position to obtain safe and effective imaging of structures other than the brain.

Description

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.)

Time Frame

2 Weeks

Title

Evoked activity to obtain safe and effective imaging of structures other than the brain

Description

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.)

Time Frame

2 Weeks

Secondary Outcome Measure Information:

Title

Dominant frequency of non-brain electrical activity in healthy adults.

Description

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.)

Time Frame

2 Weeks

Title

Location of non-brain of activity in healthy adults.

Description

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.)

Time Frame

2 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adults who are willing and able to provide informed consent. Exclusion Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodolfo Llinas, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG (BODMEG)

Chronic Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial