Peripheral Nerve Activation Sensitivity (PERNEAC)

Peripheral Nerve Activation Sensitivity to Electromagnetic and Electrical Stimulation in the Upper Arm

Volunteers will undergo various peripheral nerve stimulations (electric, electromagnetic, and temporal interference) to evaluate each method's sensitivity. The main objective is to examine the relationship between nerve activation and coil placement relative to the nerve, as well as how different coil types influence maximal nerve activation.

Study Overview

• Status: Recruiting
• Conditions: Nerve Excitation Sensitivity
• Intervention / Treatment: Device: Electric and electromagnetic stimulation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Niederhauser, PhD; Phone Number: +41 32 321 67 63; Email: thomas.niederhauser@bfh.ch

Study Locations

• Switzerland
  • Biel
    • Biel, Biel, Switzerland, 2502
      • Recruiting
      • Institute for Human Centered Engineering HuCE
      • Contact: Thomas Niederhauser, Prof. Dr.; Phone Number: +41 32 321 67 63; Email: thomas.niederhauser@bfh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Person aged > 18 years
• Signed informed consent
• Healthy
• Willingness and ability to adhere to study procedures

Exclusion Criteria:

• Known hypersensitivity to electric or electromagnetic stimulation
• Any implanted metal or electronic device in the upper body (except dental work such as fillings or braces), e.g., active medical devices, metal implants
• Neurological or neuromuscular disorders or conditions
• History of seizures or epilepsy
• Current treatment with drugs that lower seizure threshold (e.g., certain analgesics, methylxanthines, antipsychotics, antidepressants, antiepileptics, anesthetics)
• Pregnancy or breastfeeding
• Surgical intervention of the arm within the last 4 weeks
• Allergy to adhesives or ultrasound gel components (e.g., polyethylene glycols)
• Skin lesions, infections, or strictures in the arm region
• Tattoos on the stimulated (right) arm and hand, or in any area likely to be captured in video recordings
• Inability to follow study procedures (e.g., due to language barrier, psychological disorders, dementia)
• Participant deprived of liberty by administrative or judicial decision or under legal guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulated	Device: Electric and electromagnetic stimulation; Application of electromagnetic and electric stimulation using coils of different designs and electrodes to assess peripheral nerve sensitivity. The stimulation is momentary, non-therapeutic, and performed for basic science research purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum nerve activation response to electromagnetic stimulation with different coils	Maximum of the measured signals (muscle contraction from electromyography (EMG) and finger movement from accelerometer) obtained across all stimulation positions at a given stimulation intensity for each coil type. This reflects the relative sensitivity of peripheral nerves to electromagnetic stimulation with different coil designs.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatial range of nerve activation with electromagnetic coils	Distance around the stimulation position yielding the maximum response (E1), within which the measured signals (muscle contraction and finger movement) remain at least 50% of the maximum, across all coil positions at a given stimulation intensity.	Day 1
Spatial range of nerve activation with neuromuscular electrical stimulation electrodes (NMES)	Distance around the stimulation position yielding the maximum response, within which the measured signals (muscle contraction and finger movement) remain at least 50% of the maximum, across all NMES electrode positions at a given stimulation intensity.	Day 1
Amplitude ratios of temporal interference stimulation (TIS) electrodes associated with nerve activation	Electrode amplitude ratios during Temporal Interference Stimulation (TIS) for which measured signals remain at least 50% of the maximum signals observed at the optimal position.	Day 1

Collaborators and Investigators

• Sponsor: Thomas Niederhauser
• Collaborators: Bern University of Applied Sciences; Swiss Paraplegic Research, Nottwil

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 29, 2025
• First Submitted That Met QC Criteria: August 29, 2025
• First Posted (Estimated): September 8, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Peripheral nerve stimulation; Magnetic and electric stimulation; Sensitivity of nerves to magnetic fields
• Other Study ID Numbers: 2025-00776; 108.018 IP-LS (Other Grant/Funding Number: Innosuisse)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No