NCT03232723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2017

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

July 25, 2017

Last Update Submit

June 3, 2019

Conditions

Chronic Pain

Keywords

MagnetoencephalographyWhole-cortex MEG System (with optional EEG)

Outcome Measures

Primary Outcomes (2)

  • 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.)

    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.)

    2 Weeks

Secondary Outcomes (2)

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

    2 Weeks

  • Location of non-brain of activity in healthy adults.

    2 Weeks

Study Arms (1)

MEG Recording

OTHER

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

Diagnostic Test: Whole-cortex MEG System (with optional EEG)

Interventions

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.

MEG Recording

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rodolfo Llinas, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 28, 2017

Study Start

August 1, 2017

Primary Completion

September 7, 2017

Study Completion

September 7, 2017

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations

US(1)