NCT01740843

Brief Summary

In this study the effect of tDCS intensity on motor performance and corticospinal (CS) excitability is evaluated. The investigators expect that a positive relationship between current intensity and motor performance/CS excitability.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

8 months

First QC Date

November 26, 2012

Last Update Submit

February 24, 2014

Conditions

Cortical ExcitabilityMotor PerformancetDCS

Outcome Measures

Primary Outcomes (2)

  • Change in motor performance

    motor performance is assessed using different reaction time paradigms (simple reaction time, choice reaction time). This is done at baseline and immediately after the intervention (30 min after baseline)

    Baseline and POST (30 min after baseline) intervention

  • Change in cortical excitability

    Cortical excitability is measured using trancranial magnetic stimulation (TMS) measuring muscle evoked potentials (MEPs) at baseline and POST (30 min after baseline).

    Baseline and POST (30 min after baseline) intervention

Study Arms (3)

Low intensity anodal tDCS

ACTIVE COMPARATOR

tDCS will be administered for 10 min at 1mA

Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)

High intensity anodal tDCS

EXPERIMENTAL

tDCS will be administered for 10 min at 2.5mA

Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)

Sham tDCS

SHAM COMPARATOR

Sham will be administered for 10 min at 0 mA

Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)

Interventions

transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)DEVICE

The anode is fixed on the primary cortex and the cathode will be fixed on the contralateral supraorbital region.

Also known as: NeuroConn DC-stimulator
High intensity anodal tDCSLow intensity anodal tDCSSham tDCS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Healthy subjects

You may not qualify if:

  • Contraindications for tDCS/TMS
  • TMS measurements have to be possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs. Koen Cuypers

Study Record Dates

First Submitted

November 26, 2012

First Posted

December 4, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

February 25, 2014

Record last verified: 2014-02