Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03223636
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2017-07-19
Brief Title:
Measuring the Latency Connectome in the Central Nervous Systems Using Neuroimaging and Neurophysiological Techniques
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Measuring the Latency Connectome in the Central Nervous System Using Neuroimaging and Neurophysiological Techniques
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Objectives
We are proposing the development and assessment of an MRI and neurophysiology-based experimental and theoretical framework to measure peripheral and intercortical latencies and latency distributions in the living human This entails combining and integrating neurophysiological and neuroimaging so that we can eventually generate latency and latency distribution matrices for central nervous systems CNS using neuroimaging techniques Neuroimaging and neurophysiological studies in the peripheral nerve system PNS will provide essential data for proof-of-concept and for validating this approach
Study Population
We intend to study up to 40 healthy volunteers Each subject will complete 1 to 8 visits involving various measurements with different neuroimaging and neurophysiological techniques
Design
This is an exploratory study that consists of different measurements using multimodal neurophysiological and neuroimaging techniques Diffusion magnetic resonance imaging MRI mean apparent propagator MAP-MRI AxCaliber MRI multiple pulsed field gradient MRI and resting-state functional MRI will be performed in 1 to 2 visits In another 1 to 5 visits we will use neurophysiological techniques including peripheral electrical stimulation transcranial magnetic stimulation TMS electroencephalography EEG and magnetoencephalography MEG with various experimental paradigms to correlate with the latency and latency distribution matrices generated by neuroimaging techniques All these techniques are exploratory and success or failure of one of them does not have immediate implications for the others
Outcome Measures
We will measure average axon diameter AAD and axon diameter distributions ADD as well as compute white matter pathway trajectories using diffusion MRI and MAP-MRI data and use resting-state functional MRI to measure blood oxygenation level-dependent signal to identify salient cortical regions in which many of these tracts terminate For proof-of-concept measurements in the PNS compound muscle action potential or surface compound nerve action potential on the skin will be measured following peripheral nerve stimulation For TMS we will measure motor evoked potential MEP amplitude Cortical evoked potential in different cortical areas induced by TMS will be measured in EEG recordings We will study millisecond coupling delays between different cortical areas with MEG We will measure time and phase delays as computed from whole-head signals in the subject Coherence analysis for cortical activity with EEG and MEG recordings between different cortical areas will be performed We will attempt to correlate MRI measurements with the individual physiological measurements
We are proposing the development and assessment of an MRI and neurophysiology-based experimental and theoretical framework to measure peripheral and intercortical latencies and latency distributions in the living human This entails combining and integrating neurophysiological and neuroimaging so that we can eventually generate latency and latency distribution matrices for central nervous systems CNS using neuroimaging techniques Neuroimaging and neurophysiological studies in the peripheral nerve system PNS will provide essential data for proof-of-concept and for validating this approach
Study Population
We intend to study up to 40 healthy volunteers Each subject will complete 1 to 8 visits involving various measurements with different neuroimaging and neurophysiological techniques
Design
This is an exploratory study that consists of different measurements using multimodal neurophysiological and neuroimaging techniques Diffusion magnetic resonance imaging MRI mean apparent propagator MAP-MRI AxCaliber MRI multiple pulsed field gradient MRI and resting-state functional MRI will be performed in 1 to 2 visits In another 1 to 5 visits we will use neurophysiological techniques including peripheral electrical stimulation transcranial magnetic stimulation TMS electroencephalography EEG and magnetoencephalography MEG with various experimental paradigms to correlate with the latency and latency distribution matrices generated by neuroimaging techniques All these techniques are exploratory and success or failure of one of them does not have immediate implications for the others
Outcome Measures
We will measure average axon diameter AAD and axon diameter distributions ADD as well as compute white matter pathway trajectories using diffusion MRI and MAP-MRI data and use resting-state functional MRI to measure blood oxygenation level-dependent signal to identify salient cortical regions in which many of these tracts terminate For proof-of-concept measurements in the PNS compound muscle action potential or surface compound nerve action potential on the skin will be measured following peripheral nerve stimulation For TMS we will measure motor evoked potential MEP amplitude Cortical evoked potential in different cortical areas induced by TMS will be measured in EEG recordings We will study millisecond coupling delays between different cortical areas with MEG We will measure time and phase delays as computed from whole-head signals in the subject Coherence analysis for cortical activity with EEG and MEG recordings between different cortical areas will be performed We will attempt to correlate MRI measurements with the individual physiological measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-N-0128 | None | None | None |