Transcranial Direct Current StimulationNCT06122155
Effects of Posterior Parietal Cortex and Cerebellum Anodal tDCS on Ankle Tracking Visuomotor Adaptation
A study testing Transcranial direct current stimulation (Anodal) in people with Transcranial Direct Current Stimulation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Direct Current Stimulation
- What is being tested?
- Transcranial direct current stimulation (Anodal)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Nov 2022to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Transcranial Direct Current Stimulation
- Being tested
- Transcranial direct current stimulation (Anodal), Transcranial direct current stimulation (Sham)
- Keywords
- Transcranial Direct Current Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (Anodal)Device
20-minutes, 2 mA anodal tDCS delivering through two 5 cm x 7 cm electrodes
Transcranial direct current stimulation (Sham)Device
20-minutes, 0 mA anodal tDCS delivering through two 5 cm x 7 cm electrodes
| Study group | Role | What they receive |
|---|---|---|
| Posterior parietal cortex (PPC) | Experimental | 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. Receives: Device: Transcranial direct current stimulation (Anodal) |
| Cerebellum | Experimental | 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. Receives: Device: Transcranial direct current stimulation (Anodal) |
| Sham | Sham comparator | 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. Receives: Device: Transcranial direct current stimulation (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block root-mean squared error (RMSE)
RMSE is the error between target trajectory and subject cursor trajectory. Every 5 trials of RMSE were averaged into one block.
Measured: 2 hours during the time of assessment of the participant
RMSE reduction rate
ΔRMSEi-(i+1) = (RMSEi - RMSEi+1) / RMSEi x 100%
Measured: 2 hours during the time of assessment of the participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start26 Nov 2022
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122155
- Sponsor's protocol ID
- 202204075DINB
- Status last verified
- May 2022
- First submitted
- 29 Oct 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating How Cortical Modulation of the Cerebellum and Posterior Parietal Cortex Using Anodal tDCS Influences Ankle Motor Adaptation After Motor Learning
- ClinicalTrials.gov ID
- NCT06122155
- Acronym / sponsor ID
- 202204075DINB
- Conditions
- Transcranial Direct Current Stimulation
- Keywords
- Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Posterior parietal cortex (PPC) | Experimental | Device: Transcranial direct current stimulation (Anodal)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. |
| Cerebellum | Experimental | Device: Transcranial direct current stimulation (Anodal)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. |
| Sham | Sham comparator | Device: Transcranial direct current stimulation (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. |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (Anodal)20-minutes, 2 mA anodal tDCS delivering through two 5 cm x 7 cm electrodes | Device | Cerebellum, Posterior parietal cortex (PPC) |
| Transcranial direct current stimulation (Sham)20-minutes, 0 mA anodal tDCS delivering through two 5 cm x 7 cm electrodes | Device | Sham |
Primary outcome
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.
RMSE reduction rate
Time frame: 2 hours during the time of assessment of the participant
ΔRMSEi-(i+1) = (RMSEi - RMSEi+1) / RMSEi x 100%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (Anodal) in people with Transcranial Direct Current Stimulation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block root-mean squared error (RMSE) (time frame: 2 hours during the time of assessment of the participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.