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HealthyNCT06471244

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

A study testing Finger tapping, Median nerve stimulation and Speech processing in people with Healthy, run by Worcester Polytechnic Institute at 2 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Finger tapping, Median nerve stimulation and Speech processing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesGermany
Study dates
1 Jan 2025to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sergey N Makaroff, PhD contact

508-831-5017

snmakaroff@wpi.edu

Germany2 sites, 2 recruiting
  • Technical University Ilmenau

    Ilmenau

    Jens Haueisen, PhD, +49 (0) 3677 69-2860, jens.haueisen@tu-ilmenau.de

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

    Leipzig

    Burkhard Maess, PhD, +49 341 9940-2526, maess@cbs.mpg.de

    Recruiting

Other trials in Germany

About this study

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.
Read more

Participants will:

  • Undergo Magnetic Resonance Imaging (MRI) scans for brain and head model creation
  • Undergo three different EEG tests
  • Undergo three different MEG tests
Read the detailed description

Magnetic Resonance Imaging (MRI) head/neck scans of 30 healthy subjects using the 7 Tesla Siemens Scanner will be performed 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 sequences. Construction of computational head models from the MRI data using FreeSurfer and Charm segmentation software packages will be performed at Worcester Polytechnic Institute.

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.

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.

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).

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.

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.

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).

The main questions it aims to answer are:

Does the proposed high-resolution testbed better localize brain sources for finger movement?

Does the proposed high-resolution testbed better localize brain sources for median nerve stimulation?

Does the proposed high-resolution testbed better localize brain sources for speech processing?

Conditions
Healthy
Being tested
Finger tapping, Median nerve stimulation, Speech processing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Finger tappingOther

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

  • Median nerve stimulationOther

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

  • Speech processingOther

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

Study groups in NCT06471244
Study groupRoleWhat they receive
EEG/MEG data collection and processing with high density recording techniquesExperimentalNot described
Receives: Other: Finger tapping; Other: Median nerve stimulation; Other: Speech processing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. 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).

    Measured: 1 year

  5. 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.

    Measured: through study completion, an average of 1 year

  6. 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.

    Measured: through study completion, an average of 1 year

  7. 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).

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start1 Jan 2025
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06471244
Sponsor's protocol ID
24-0779
Status last verified
May 2025
First submitted
20 May 2024
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It is our firm intention to share our MRI/EEG/MEG datasets and resources with the broader neuroimaging and general scientific communities. The BEM-FMM computational package(s), along with the manual(s), application examples and supporting experimental data/human models, will be made available to interested researchers and collaborators, based on the widely accessible MATLAB platform for Windows and Linux following publication. Researchers with approved access to NIH-supported Scientific Data Repositories - the National Data Archive Database will be able to access raw experimental data from this project to enable sufficient independent validation efforts and to allow for replication of the research findings. The data will be available at The National Institute of Mental Health Data Archive (NDA) in accordance with the NIH Principles and Guidelines.

Questions about this trial

What is this clinical trial studying?

A study testing Finger tapping, Median nerve stimulation and Speech processing in people with Healthy, run by Worcester Polytechnic Institute at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sergey N Makaroff, PhD (508-831-5017, snmakaroff@wpi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI T1/T2 head/neck scans of 30 healthy subjects (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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