NCT02837458

Brief Summary

The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

February 19, 2020

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

July 15, 2016

Last Update Submit

February 17, 2020

Conditions

High Frequency Current

Keywords

Electric currentNerve blocksomatosensory evaluation

Outcome Measures

Primary Outcomes (6)

  • Baseline Mechanical Pain Threshold

    The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton

    baseline at 0 min

  • Baseline Tactile Threshold

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

    baseline at 0 min

  • Baseline Muscle Strength

    The muscle strength will be measured with a dynamometer and will be expressed in Newton

    Baseline at 0 min

  • Mechanical Pain Threshold after treatment at 30 min

    The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton

    Immediately after treatment at 30 min

  • Tactile Threshold after treatment at 30 min

    The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton

    Immediately after treatment at 30 min

  • Muscle Strength after treatment at 30 min

    The muscle strength will be measured with a dynamometer and will be expressed in Newton

    Immediately after treatment at 30 min

Secondary Outcomes (3)

  • Change from baseline in Mechanical Pain Threshold

    baseline at 0 min, immediately after treatment at 30 min

  • Change from baseline in TactileThreshold

    baseline at 0 min, immediately after treatment at 30 min

  • Change from baseline in Muscle strength

    baseline at 0 min, immediately after treatment at 30 min

Study Arms (2)

High-Frequency

EXPERIMENTAL

Transcutaneous application of high frequency electrical current over the arm for a 30 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold.

Device: High-Frequency

Sham Stimulation

SHAM COMPARATOR

Electrodes are placed over the arm for a 30 minutes in the same manner as experimental group but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.

Device: Sham Stimulation

Interventions

High-FrequencyDEVICE

high-Frequency electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

High-Frequency
Sham StimulationDEVICE

Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Sham Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Neuromuscular disease.
  • Epilepsy.
  • Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
  • Osteosynthesis material in the upper limb.
  • Diabetes.
  • Cancer.
  • Cardiovascular disease.
  • Pacemaker or other implanted electrical device.
  • Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
  • Presence of tattoos or other external agent introduced into the treatment or assessment area.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diego Serrano-Muñoz

Toledo, 45004, Spain

Location

Related Publications (1)

  • Serrano-Munoz D, Avendano-Coy J, Simon-Martinez C, Taylor J, Gomez-Soriano J. 20-kHz alternating current stimulation: effects on motor and somatosensory thresholds. J Neuroeng Rehabil. 2020 Feb 19;17(1):22. doi: 10.1186/s12984-020-00661-x.

    PMID: 32075666DERIVED

Study Officials

  • Diego Serrano-Muñoz, MsC

    Hospital Nacional de Parapléjicos, Toledo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 19, 2016

Study Start

May 1, 2017

Primary Completion

September 30, 2017

Study Completion

December 20, 2017

Last Updated

February 19, 2020

Record last verified: 2017-04

Locations

ES(1)