Measuring the Latency Connectome in the Central Nervous Systems Using Neuroimaging and Neurophysiological Techniques

NCT03223636 | Completed FDA Device

• 2 other identifiers: 17012817-N-0128
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Little is known about the time it takes for nerve signals to go from one area of the brain to another. Using advanced methods for brain research, researchers want to look at the time it takes to send messages between different brain areas. They also want to develop new tests. Objectives: To develop tests to measure the sizes of nerve fibers in the peripheral nerve system and in the brain. Also to find out the different speeds that information travels in nerve fibers. Eligibility: Healthy, right-handed people ages 18-70 Design: Participants will be screened with medical history and a physical exam. Participants will have up to 7 visits depending on the tests they choose. Visits last about 2-4 hours and may involve the following tests:

• Physical exam
• Urine tests
• Magnetic resonance imaging (MRI). Participants lie on a table that slides into a scanner. They will be in the scanner for up to 1 hour. For some scans, sensors are placed on the skin. They will get earplugs for loud noises.
• Small, sticky pads on the skin will electrically stimulate nerves in the forearm.
• Transcranial magnetic stimulation (TMS). A wire coil will be held to the scalp. A brief electrical current passes through the coil to affect brain activity.
• Electroencephalography. TMS will be given to the brain. Small electrodes on the scalp measure brain activity. Participants may do small tasks.
• Electrodes on the scalp will send an electrical current to the brain.
• A cone with magnetic detectors will be lowered onto the head to record brain activity. Participants will perform various tasks.

Conditions

Healthy Volunteers

Keywords

Transcranial Magnetic Stimulation (TMS); Magnetic Resonance Imaging (MRI); Electroencephalogram (EEG); Magnetoencephalogram; Transcranial Electrical Stimulation (TES)

Outcome Measures

Primary Outcomes (1)

• measure motor evoked potential (MEP) amplitude

  For TMS, we will measure motor evoked potential (MEP) amplitude

  throughout

Study Arms (1)

Healthy Volunteers

Healthy Volunteers

Device: TMS; Device: MRI

Interventions

TMS DEVICE

We will use TMS with paired-pulse technique to activate corticospinal neurons in the primary motor cortex and motorneurons in the brainstem, respectively (Hallett 2007; Ugawa et al. 1991; Ugawa et al.1994). Two stimulations will be separated with various interstimulus intervals to produce collision on nerve fibers with different conduction velocity in the corticospinal tract. The conduction time on nerve fibers in the corticospinal tract with different conduction velocity will be identified and the distribution of these fibers will be calculated.

Healthy Volunteers

MRI DEVICE

MRI exams will consist of several sessions including calibration, anatomic, and diffusion MRI scanning (Avram et al. 2013; Avram et al. 2016; Pierpaoli et al. 1996). Data in each exam will be acquired in the left or right forearm (PNS).

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• Ages between 18-70 years.
• Right-handed (tested by the Edinburg handedness inventory).
• Able to give informed consent and able to comply with all study procedures.

You may not qualify if:

• Self-reported consumption of \>14 alcoholic drinks/week for a man and \>7 alcoholic drinks/week for a woman.
• Abnormal findings on neurological examination.
• History of brain tumor, stroke, head trauma with loss of consciousness, epilepsy or seizures.
• Current episode of any major psychiatric illness.
• Use of medications that act directly on the CNS.
• Hearing loss reported in the history or detected in the routine physical examination
• Having permanent tattooed makeup (eyeliner, lip, etc.) or general tattoos. Subjects with tattoos will be excluded if those are in a dangerous location in the body or made with colors (e.g. dark blue and dark green) whose content in iron cannot be definitely ruled out by the investigators.
• Having non-organic implant or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch, any metallic implants or objects, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunt.
• Having cerebral or other aneurysm clips.
• Having shrapnel or other metal imbedded in the body (such as from war wounds or accidents).
• Had severe accidents in the past that may possibly have left metal in the body.
• Previously worked in metal fields or with machines that may have left any metallic fragments in or near eyes.
• Having any psychological contraindications for MRI (e.g., suffer from claustrophobia, unable to lie comfortably on your back for 2 hours).
• Discomfort being in a small space for the expected length of the experiment, up to 2 hours.
• Pregnancy.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Ni Z, Leodori G, Vial F, Zhang Y, Avram AV, Pajevic S, Basser PJ, Hallett M. Measuring latency distribution of transcallosal fibers using transcranial magnetic stimulation. Brain Stimul. 2020 Sep-Oct;13(5):1453-1460. doi: 10.1016/j.brs.2020.08.004. Epub 2020 Aug 11.

  PMID: 32791313 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: October 2, 2017
• Primary Completion: November 12, 2020
• Study Completion: February 26, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-03

Locations

US (1)