Effects of Posterior Parietal Cortex and Cerebellum Anodal tDCS on Ankle Tracking Visuomotor Adaptation

November 9, 2023 updated by: National Taiwan University Hospital

Investigating How Cortical Modulation of the Cerebellum and Posterior Parietal Cortex Using Anodal tDCS Influences Ankle Motor Adaptation After Motor Learning

Motor adaptation is guided by state estimation, a dynamic prediction of the interaction consequences between body and environment in the sensorimotor system. Previous studies have shown that the posterior parietal cortex (PPC) and cerebellum are potential candidates for state estimators. However, neither direct evidence linking neural substrates of state estimation and motor adaptation nor the differences in state estimation in these two brain areas was presented. A comparison of neuromodulation effects over PPC and cerebellum in motor adaptation tasks could provide direct evidence to solve the knowledge gap.

Objective: This study aims to provide direct evidence to link state estimation and motor adaptation, and the neuromodulation effects of PPC and cerebellum in motor adaptation by using anodal transcranial direct current stimulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This was a single-blind, sham-controlled study. All participants were randomized to the PPC, cerebellum, and sham stimulation group. The ankle tracking system was used to record the ankle tracking visuomotor task during the motor learning phase, motor adaptation phase, and motor re-adaptation phase. Normalized root-mean squared error (RMSE) and RMSE reduction rate were measured as the performance outcome. A 20-minute atDCS at 2 mA anodal tDCS was given during the motor adaptation phase. The immediate effect and after effect of tDCS were seen in the motor adaptation phase and motor re-adaptation phase, respectively.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Taipei, Taiwan, 100
        • National Taiwan 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age between 20~29 years old
  • normal ankle range of motion and muscle strength
  • intact cognitive function (Mini-mental State Examination (MMSE) >27)
  • corrected vision > 0.9.

Exclusion Criteria:

  • any neurologic or psychiatric disease history
  • musculoskeletal disease that interferes lower extremities movement
  • severe cardiopulmonary or systematic disease (e.g. unstable angina, severe arrhythmia, heart failure, hypertrophic cardiomyopathy, aortic stenosis, pulmonary embolism, kidney failure)
  • paresthesia
  • seizure history
  • brain surgery, meningitis, encephalitis history
  • drainage tube on the head
  • metal or other insertion in the brain
  • insertion of electric medical device (e.g. pacemaker, cochlear implant)
  • pregnancy
  • taking central nervous system medication (e.g. antidepressants, anxiolytic)
  • alcoholic addiction or drug abuse
  • open wound, allergy, rash, or other illness that would affect the placement of tDCS
  • headache, disgusting, vomit, or any other severe side effect to the tDCS

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Posterior parietal cortex (PPC)
In the motor adaptation phase, a 20-minute, 2 mA anodal tDCS was delivered through two 5cm x 7cm electrodes using the DC-STIMULATOR MR (neuroConn, Germany). The electrical current gradually ramps up and down in 20 seconds. In the PPC group, the anodal electrode was placed over the P3 or P4 areas on the skull, covering the PPC area on the opposite side of the testing foot (according to the international 10-20 EEG system), and the reference electrode was placed over the supraorbital region on the same side of the testing foot.
Device: Transcranial direct current stimulation (Anodal)
20-minutes, 2 mA anodal tDCS delivering through two 5 cm x 7 cm electrodes
Experimental: Cerebellum
In the motor adaptation phase, a 20-minute, 2 mA anodal tDCS was delivered through two 5cm x 7cm electrodes using the DC-STIMULATOR MR (neuroConn, Germany). The electrical current gradually ramps up and down in 20 seconds. In the cerebellum group, the anodal electrode was placed 1~2 cm under and 3~4 cm lateral to the inion on the same side of the testing foot, with the reference electrode placed on the buccinator on the same side of the testing foot.
Device: Transcranial direct current stimulation (Anodal)
20-minutes, 2 mA anodal tDCS delivering through two 5 cm x 7 cm electrodes
Sham Comparator: Sham
In the motor adaptation phase, a 20-minute, 0 mA anodal tDCS was delivered through two 5cm x 7cm electrodes using the DC-STIMULATOR MR (neuroConn, Germany) for the sham group. Participants were informed that they might experience itchiness, burning, or mild discomfort during the tDCS period regardless of which group they were assigned to, so they would not use their sensation as a basis for determining whether they received actual stimulation or not.
Device: Transcranial direct current stimulation (Sham)
20-minutes, 0 mA anodal tDCS delivering through two 5 cm x 7 cm electrodes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Block root-mean squared error (RMSE)
Time Frame: 2 hours during the time of assessment of the participant
RMSE is the error between target trajectory and subject cursor trajectory. Every 5 trials of RMSE were averaged into one block.
2 hours during the time of assessment of the participant
RMSE reduction rate
Time Frame: 2 hours during the time of assessment of the participant
ΔRMSEi-(i+1) = (RMSEi - RMSEi+1) / RMSEi x 100%
2 hours during the time of assessment of the participant

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science and Technology Council

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202204075DINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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