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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03232723
Other study ID # 17-00684
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date September 7, 2017

Study information

Verified date June 2019
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 7, 2017
Est. primary completion date September 7, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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.)
2 Weeks
Secondary 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.)
2 Weeks
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