Transcutaneous Electrical Nerve Inhibition Using Medium-frequency Alternating Current

NCT04827173 | Completed

• 1 other identifier: f/2021/013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Patients suffering from neurological disorders often exhibit unwanted sensorimotor activities e.g. spasticity, hypersensitisation, hyper- and dystonia and motor disabilities. Currently, several therapeutic interventions are developed and implemented to overcome these unwanted activities e.g. transcutaneous electrical stimulation (TES), oral medication, botulinum neurotoxin injections, local anaesthetics, rehabilitation robotic training and surgery. However, these therapies offer varying results. Compared to analgesic drugs, TES is associated with fewer side effects and has therefore become a popular therapeutic strategy to treat these unwanted sensorimotor activities. To enable this TES strategy, surface electrodes are attached to the skin overlying the site of pain. Next, a low-frequency electrical current (LFC; 1-100 Hz) is applied. However, this low-frequency current acts as an excitatory agent and results in muscle contraction. Therefore, this technique cannot be used to treat unwanted motor activities. Electrical stimulation with medium-frequency alternating electrical currents (MFAEC; 2-50 kHz) can inhibit peripheral motor nerve activities and force production, when implanted directly on top of the peripheral nerve of interest. However, this strategy is rather invasive. Thus, the administration of transcutaneous medium-frequency alternating electrical currents (tMFAEC), i.e. administration of electrical currents through the skin, might offer a solution. However, the effects of tMFAEC on motor nerve inhibition remains largely unknown. Theoretically, the administration of tMFAEC on the sensory nerve may even result in partial or complete (reversible) nerve block thereby serving as an anesthesia in order to perform surgical or painful procedures.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (3)

• Sensory perception: tactile sensation

  Assessment of tactile sensory perception in the index finger when tMFAEC is applied with a fixed current intensity of 31.5mA at a frequency of 10kHz to the distal median nerve. The tactile sensory perception will be measured with the Semmes-Weinstein monofilament examination. Tactile sensation will be measured in grams (g).

  10 minutes

• Force Production

  Assessment of force production in the index and middle finger when tMFAEC is applied with a fixed current intensity of 31.5mA at a frequency of 10kHz to the distal median nerve. The assessment of force production will be measured with an electronic handheld dynamometer (MicroFET2) and the peak force will be measured in Newton (N).

  5 minutes

• Sensory perception: pressure sensation

  Assessment of pressure sensory perception in the index finger when tMFAEC is applied with a fixed current intensity of 31.5mA at a frequency of 10kHz to the distal median nerve. The pressure sensory perception will be measured with a pressure algometer. Tactile sensation will be measured in kilograms per squared centimeter (kg/cm²).

  5 minutes

Secondary Outcomes (4)

• Safety: peak current intensity

  2 minutes

• Effect of different frequency

  20 minutes

• Effect of different type of electrode

  20 minutes

• Effect of the depth of the median nerve

  2 minutes

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Procedure: transcutaneous medium-frequency alternating current

Interventions

transcutaneous medium-frequency alternating current PROCEDURE

Patients receive nerve block of right forearm through transcutaneous medium-frequency alternating current

Healthy volunteers

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers \> 18 years old

You may not qualify if:

• Musculoskeletal pain
• Neurologic disorder
• Diabetes mellitus
• Hypertension
• Autoimmune disease
• Any type of surgical history
• Allergy for the electrode patches

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Anesthesiology

Hasselt, 3500, Belgium

Location

Related Publications (1)

• Maris S, Brands M, Lenskens D, Braeken G, Kemnitz S, Vanhove H, Mc Laughlin M, Meesen R, Brone B, Stessel B. Transcutaneous electrical nerve inhibition using medium frequency alternating current. Sci Rep. 2022 Sep 1;12(1):14911. doi: 10.1038/s41598-022-18974-3.

  PMID: 36050354 DERIVED

Study Design

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

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: April 1, 2021
• Study Start: April 9, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-01

Locations

BE (1)