NCT04618614

Brief Summary

to investigate the effect of transcranial direct current stimulation of the somatosensory area on upper limb motor performance in healthy adults

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

November 1, 2020

Last Update Submit

January 31, 2022

Conditions

Healthy

Keywords

transcranial direct current stimulation, motor performance

Outcome Measures

Primary Outcomes (9)

  • 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 will be greater than 5% of the peak tangential velocity). Improved motor performance will be 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 will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.

    Baseline (immediately before stimulation), immediately post 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 will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.

    Two minutes after starting the stimulation, immediately post 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 will be 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 will be indicated by a shorter reaction time.

    Baseline (immediately before stimulation), immediately post 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 will be indicated by a shorter reaction time.

    Two minutes after starting the stimulation, immediately post stimulation

  • Change in straight line deviation (cm) from baseline to intervention

    Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.

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

  • Change in straight line deviation (cm) from baseline to posttest

    Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.

    Baseline (immediately before stimulation), immediately post stimulation

  • Change in straight line deviation (cm) from intervention to posttest

    Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.

    Two minutes after starting the stimulation, immediately post stimulation

Secondary Outcomes (2)

  • Change in the correct answers (%) of discriminative task from baseline to posttest

    Baseline (immediately before stimulation), immediately after the motor posttest

  • Change in end point error (cm) of proprioception task from baseline to posttest

    Baseline (immediately before stimulation), immediately after the motor posttest

Study Arms (3)

HD-tDCS S1 1 mA

EXPERIMENTAL

Single session of 15-min HD-tDCS to the right primary somatosensory cortex with an intensity of 1 mA. The session will last approximately one hour.

Device: HD-tDCS 1 mA to S1

HD-tDCS M1 1 mA

ACTIVE COMPARATOR

Single session of 15-min HD-tDCS to the right primary motor cortex with an intensity of 1 mA. The session will last approximately one hour.

Device: HD-tDCS 1 mA to M1

Sham control

SHAM COMPARATOR

Single session of 15-min HD-tDCS to the right primary somatosensory cortex with an intensity of 1 mA. The session will last approximately one hour.

Device: Sham control

Interventions

HD-tDCS 1 mA to S1DEVICE

Anodal high definition transcranial direct current stimulation of the right primary somatosensory cortex with an intensity of 1 mA

HD-tDCS S1 1 mA
HD-tDCS 1 mA to M1DEVICE

Anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1 mA

HD-tDCS M1 1 mA
Sham controlDEVICE

Sham stimulation of the right primary somatosensory cortex

Sham 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 / alcohol 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

Study Officials

  • Silvi Frenkel-Toledo, PhD

    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

November 1, 2020

First Posted

November 6, 2020

Study Start

November 10, 2020

Primary Completion

January 7, 2021

Study Completion

April 1, 2022

Last Updated

February 1, 2022

Record last verified: 2021-01

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) will be available from the corresponding author on reasonable request.

Locations

IL(1)