Development of Electroencephalography (EEG) and Magnetoencephalography (MEG) Source Reconstruction With Fast Multipole Method

NCT06471244 | Recruiting

• 1 other identifier: 24-0779
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if an advanced 256 dry electrode EEG cap augmented with MEG readings and coupled with a new high-resolution fast brain modeling software gives a better EEG and MEG source localization in real time. The main questions it aims to answer are:

• Does the testbed better localize brain sources for finger movement?
• Does the testbed better localize brain sources for median nerve stimulation?
• Does the testbed better localize brain sources for speech processing?
• Researchers will compare the predicted cortical locations with MEG data and known anatomical locations of the neuronal generators. Participants will:
• Undergo Magnetic Resonance Imaging (MRI) scans for brain and head model creation
• Undergo three different EEG tests
• Undergo three different MEG tests

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• MRI T1/T2 head/neck scans of 30 healthy subjects

  Magnetic Resonance Imaging (MRI) head/neck scans of 30 healthy subjects using the 7 Tesla Siemens Scanner at the Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig Germany with 0.5/0.7 mm isotropic resolution, for both T1 and T2 imaging sequencies. Construction of computational head models from the MRI data using FreeSurfer and Charm segmentation software packages.

  1 year

• EEG measurements of cortical activity in response to index finger tapping for 30 subjects

  On-skin voltage recordings will be done with 256 dry electrodes. Our EEG protocols will collect 240 trials per subject (3 runs of 80 trials each). German volunteers will be tapping with their right hand index finger. The corresponding neuronal generators are located in the M1INDEXFINGER/S1INDEXFINGER areas (primary motor/somatosensory cortex) at different latencies.

  1 year

• EEG measurements of cortical activity in response to median nerve stimulation for 30 subjects

  On-skin voltage recordings will be done with 256 dry electrodes. Our EEG protocols will collect 240 trials per subject (3 runs of 80 trials each). .Electrical stimuli over the median nerve at the right wrist will be delivered using brief transcutaneous pulses every 1.5 seconds. The task is to respond to each stimulus by pushing a button with the left-hand index finger. This generates EEG evoked responses in the S1HAND area (primary somatosensory cortex contralateral to the nerve stimuli), and the M1HAND area (primary motor cortex) at different latencies. The P20/N20 response peaking at about 20 ms is targeted, since at this latency its neuronal generators are well-known to be located in the posterior wall of the central sulcus in the Brodmann area 3b.

  1 year

• EEG measurements of cortical activity in response to auditory signals for 30 subjects

  On-skin voltage recordings will be done with 256 dry electrodes. Our EEG protocols will collect 240 trials per subject (3 runs of 80 trials each). German sentences will be played to the volunteers and the volunteers have to fulfill a semantic task. This generates EEG evoked responses in the known areas of the Primary Auditory Cortex (PAC).

  1 year

• MEG measurements of cortical activity in response to index finger tapping for 30 subjects

  On-skin voltage recordings will be done with 256 dry electrodes. Our MEG protocols will collect 240 trials per subject (3 runs of 80 trials each). German volunteers will be tapping with their right hand index finger. The corresponding neuronal generators are located in the M1INDEXFINGER/S1INDEXFINGER areas (primary motor/somatosensory cortex) at different latencies.

  through study completion, an average of 1 year

• MEG measurements of cortical activity in response to median nerve stimulation for 30 subjects

  On-skin voltage recordings will be done with 256 dry electrodes. Our MEG protocols will collect 240 trials per subject (3 runs of 80 trials each). Electrical stimuli over the median nerve at the right wrist will be delivered using brief transcutaneous pulses every 1.5 seconds. The task is to respond to each stimulus by pushing a button with the left-hand index finger. This generates MEG evoked responses in the S1HAND area (primary somatosensory cortex contralateral to the nerve stimuli), and the M1HAND area (primary motor cortex) at different latencies. The P20/N20 response peaking at about 20 ms is targeted, since at this latency its neuronal generators are well-known to be located in the posterior wall of the central sulcus in the Brodmann area 3b.

  through study completion, an average of 1 year

• MEG measurements of cortical activity in response to auditory signals for 30 subjects

  On-skin voltage recordings will be done with 256 dry electrodes. Our MEG protocols will collect 240 trials per subject (3 runs of 80 trials each). German sentences will be played to the volunteers and the volunteers have to fulfill a semantic task. This generates EEG evoked responses in the known areas of the Primary Auditory Cortex (PAC).

  through study completion, an average of 1 year

Study Arms (1)

EEG/MEG data collection and processing with high density recording techniques

EXPERIMENTAL

Other: Finger tapping; Other: Median nerve stimulation; Other: Speech processing

Interventions

Finger tapping OTHER

The volunteer is tapping with his/her right hand index finger.

EEG/MEG data collection and processing with high density recording techniques

Median nerve stimulation OTHER

Electrical pulses are applied at the wrist to the median nerve.

EEG/MEG data collection and processing with high density recording techniques

Speech processing OTHER

German sentences are played to the volunteers and the volunteers have to fulfill a semantic task.

EEG/MEG data collection and processing with high density recording techniques

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 18 and less than 66 years
• Normal hearing and (corrected) vision
• Able to understand and give informed consent

You may not qualify if:

• Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
• Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
• Surgical clips in the head or previous neurosurgery
• Any magnetic particles in the body
• Cochlear implants
• Prosthetic heart valves
• History of skull injury or defects
• Significant claustrophobia; Ménière's disease
• Pregnancy, breast feeding
• Neurological or psychiatric diagnoses or medications influencing brain function
• Current substance abuse (exception: concurrent nicotine use is allowed)
• Failure to perform the behavioral tasks or psychological evaluation tests
• Prisoners

Sponsors & Collaborators

• Worcester Polytechnic Institute: lead
• Technische Universität Ilmenau: collaborator
• Max Planck Institute for Human Cognitive and Brain Sciences: collaborator

Study Sites (2)

Technical University Ilmenau

Ilmenau, Germany

RECRUITING

Max-Planck-Institut für Kognitions- und Neurowissenschaften [Cognitive and Neuroscience]

Leipzig, Germany

RECRUITING

Study Officials

• Sergey N Makaroff, PhD

  Worcester Polytechnic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey N Makaroff, PhD

CONTACT

508-831-5017; snmakaroff@wpi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 24, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will become available as soon as practicable under the applicable study protocols.
• Access Criteria: Access will be limited to qualified researchers through the NIMH Data Archive

Locations

DE (2)