NCT02077595

Brief Summary

Recently, non-invasive brain stimulation has become a powerful tool in both basic research and clinical application. Among several non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have received the most attention. About DC stimulation, the change of polarity could modulate the spontaneous neuronal activity and make effect on decision making, language, memory, sensory perception, and pain. In spite of that the concept of transcranial alternating current stimulation (tACS) is not novel, AC is relatively safe compared to DC, and researches have revealed that AC might potentially have the effect on the cortical excitability. However, there are still many areas about AC stimulation which remain unknown, such as mechanism, application, and potential influence on cortical excitability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

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

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

February 11, 2014

Last Update Submit

March 3, 2014

Conditions

Keywords

transcutaneous electrical nerve stimulationtranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (3)

  • Motor evoked potential

    measure of intracortical inhibition on abductor pollicis brevis by single-pulse TMS.

    Baseline

  • Intracortical inhibition, ICI

    Measure of changes in intracortical inhibition on abductor pollicis brevis by paired-pulse TMS.

    Baseline,2 hours, 2.5 hours,and 3 hours

  • intracortical facilitation, ICF

    Measure of changes in intracortical inhibition on abductor pollicis brevis by paired-pulse TMS.

    Baseline,Baseline,2 hours, 2.5 hours,and 3 hours

Study Arms (3)

120Hz alternating current stimulation group

ACTIVE COMPARATOR
Device: transcutaneous electrical nerve stimulation, TENS

5Hz alternating current stimulation group

ACTIVE COMPARATOR
Device: transcutaneous electrical nerve stimulation, TENS

sham alternating current stimulation group

SHAM COMPARATOR
Device: transcutaneous electrical nerve stimulation, TENS

Interventions

Then participants will receive stimulation for 20 minutes.

120Hz alternating current stimulation group5Hz alternating current stimulation groupsham alternating current stimulation group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2014

First Posted

March 4, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations