Effect of Transcutaneous Nerve Stimulation on Primary Motor Cortex to Modulate Cortical Excitability and Hemodynamic Response During Implicit Motor Learning: A TMS and NIRS Study

April 14, 2014 updated by: Ya-Ju Chang, Chang Gung University
Noninvasive brain stimulation was recently gradually be emphasized. The electrical current applied on scalp can effective modulate cortical excitability. Forms of Stimulation included transcranial direct current stimulation(tDCS) and transcranial alternating stimulation(tACS). tDCS had been proved the effect of cortical excitability modulation. The polarization effect of direct current stimulation can modulation specific brain area and enhance motor performance. tACS was still controversial about the effect on cortical excitability. Previous study show that the frequency dependent excitatory or inhibitory effect on cortex. The possible mechanism was to affect brain oscillation status by provided different frequency of stimulation. Transcutaneous nerve stimulation (TENS) was common used on management of chronic pain. Peripheral nerve stimulation can enhance pain or sensory evoked potential was noted. Effect of low frequency TENS on central nervous is unknown.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health Adult

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: E1
Experiment 1 will measure the cortical excitability change after TENS intervention.
Device: "Enraf-Nonius" Muscle stimulator
The order 15Hz TENS stimulation session and sham stimulation session will also be randomized.
Other Names:
  • Transcutaneous nerve stimulation
EXPERIMENTAL: E2
Experiment 2 will measures implicit sequential motor task performance and cortical hemodynamic response using near infrared spectroscopy (NIRS) during motor execution. Cortical excitability will also be measured contemporary
Device: "Enraf-Nonius" Muscle stimulator
The order 15Hz TENS stimulation session and sham stimulation session will also be randomized.
Other Names:
  • Transcutaneous nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor evoked potential
Time Frame: Baseline,0 minute,30 minutes,60 minutes.
Use single-pulse TMS to assess Motor evoked potential change.
Baseline,0 minute,30 minutes,60 minutes.
Intracortical inhibition & Intracortical facilitation
Time Frame: Baseline,0 minute,30 minutes,60 minutes.
Use paired-pulse TMS to record pre-test and post-test change.
Baseline,0 minute,30 minutes,60 minutes.
Blood oxygen dependent level
Time Frame: Baseline,in experiment,0 minute,30 minutes,60 minutes.
Use Near-infrared spectroscopy to record pre-test, in experiment, and post-test change
Baseline,in experiment,0 minute,30 minutes,60 minutes.
Implicit sequential motor task performance
Time Frame: Baseline,in experiment,0 minute,30 minutes,60 minutes.
Change of Measure of Learning curve.
Baseline,in experiment,0 minute,30 minutes,60 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

July 1, 2014

Study Completion (ANTICIPATED)

July 1, 2014

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (ESTIMATE)

April 16, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 102-2266A3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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