NCT04577768

Brief Summary

to investigate the effect of stimulation intensity on motor performance in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jul 2019

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

July 11, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

September 23, 2020

Last Update Submit

October 6, 2020

Conditions

Keywords

transcranial direct current stimulationmotor performance

Outcome Measures

Primary Outcomes (12)

  • Change in movement time (s) from baseline to intervention

    Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.

    Baseline (immediately before stimulation), two minutes after starting the stimulation

  • Change in movement time (s) from baseline to posttest

    Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.

    Baseline (immediately before stimulation), immediately post stimulation

  • Change in movement time (s) from baseline to retention test

    Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.

    Baseline (immediately before stimulation), 24 hours following the stimulation

  • Change in movement time (s) from intervention to posttest

    Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.

    Two minutes after starting the stimulation, immediately post stimulation

  • Change in movement time (s) from intervention to retention test

    Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.

    Two minutes after starting the stimulation, 24 hours following the stimulation

  • Change in movement time (s) from posttest to retention test

    Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.

    immediately post stimulation, 24 hours following the stimulation

  • Change in reaction time (s) from baseline to intervention

    Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.

    Baseline (immediately before stimulation), two minutes after starting the stimulation

  • Change in reaction time (s) from baseline to posttest

    Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.

    Baseline (immediately before stimulation), immediately post stimulation

  • Change in reaction time (s) from baseline to retention test

    Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.

    Baseline (immediately before stimulation), 24 hours following the stimulation

  • Change in reaction time (s) from intervention to posttest

    Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.

    Two minutes after starting the stimulation, immediately post stimulation

  • Change in reaction time (s) from intervention to retention test

    Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.

    Two minutes after starting the stimulation, 24 hours following the stimulation

  • Change in reaction time (s) from posttest to retention test

    Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.

    immediately post stimulation, 24 hours following the stimulation

Study Arms (3)

HD-tDCS 2 mA

EXPERIMENTAL

Single session of 20-min HD-tDCS to the right primary motor cortex with an intensity of 2 mA. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test.

Device: HD-tDCS 2 mA

HD-tDCS 1.5 mA

EXPERIMENTAL

Single session of 20-min HD-tDCS to the right primary motor cortex with an intensity of 1.5 mA. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test.

Device: HD-tDCS 1.5 mA

Control

SHAM COMPARATOR

Single session of 20-min of sham HD-tDCS. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test.

Device: HD-tDCS sham

Interventions

anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 2 mA

HD-tDCS 2 mA

anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1.5 mA

HD-tDCS 1.5 mA

sham stimulation of the right primary motor cortex

Control

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged between 20 and 35
  • right-hand dominant
  • healthy according to self report

You may not qualify if:

  • taking psychiatric medications
  • a history of drug abuse or dependence
  • psychiatric or neurological disorder
  • a history of seizures
  • metal implants in their head
  • musculoskeletal deficits interfering with task performance (proper reaching performance in sitting)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ariel University

Ariel, Israel

Location

Related Publications (1)

  • Lerner O, Friedman J, Frenkel-Toledo S. The effect of high-definition transcranial direct current stimulation intensity on motor performance in healthy adults: a randomized controlled trial. J Neuroeng Rehabil. 2021 Jun 26;18(1):103. doi: 10.1186/s12984-021-00899-z.

Study Officials

  • Silvi Frenkel-Toledo

    Ariel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled trial (RCT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 8, 2020

Study Start

July 11, 2019

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

October 8, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

The datasets (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code generated during and/or analyzed during the current study) are available from the corresponding author on reasonable request.

Locations