Transcranial Direct Current StimulationtDCSNCT06556043
Investigating the Effects of Transcranial Direct Current Stimulation to Different Brain Regions on Ankle Tracking Motor Learning, Motor Adaptation, and Brain Connectivity in Healthy Middle-aged and Older Adults and Patients With Subcortical Stroke
A study testing cM1 transcranial direct current stimulation, cPPC transcranial direct current stimulation and iCBM transcranial direct current stimulation in people with Transcranial Direct Current Stimulation and Ankle, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Ankle control is essential to safe over-ground navigation for humans. Middle- aged and older adults and patients with stroke whose ankle control is poor often lose their balance or fall. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Direct Current Stimulation, Ankle, Motor Learning
- What is being tested?
- cM1 transcranial direct current stimulation, cPPC transcranial direct current stimulation and iCBM transcranial direct current stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jul 2024to 31 Jul 2026
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Part 1: healthy middle-aged and older adults
- age between 40 and 80 years old
- intact cognitive function (MMSE ≧ 27)
- normal ankle dorsiflexor and plantarflexor strength (manual muscle strength testing= 5) and passive range of motion (ankle dorsiflexion ≧10 degrees; ankle plantarflexion ≧ 45 degrees)
- corrected far vision ≥ 0.8 (Landolt C test) and uncorrected near vision ≥ 0.04 (Comprehensive Color Blindness Checklist)
Exclusion Criteria: Part 1: healthy middle-aged and older adults
- having any contraindications for MRI or tDCS;
- serious or uncontrolled systematic diseases;
- symptoms or history of neurological diseases, including transient ischemic attack, stroke, epilepsy, history of abnormal electroencephalogram (EEG), meningitis, encephalitis, brain tumors, brain surgery, and sensory disorders, etc.;
- severe musculoskeletal problems that would affect lower limb functions;
- visual spatial perception disorders and hearing loss;
- color blindness;
- depression and psychiatric disorders;
- use of any medication that could affect the central nervous system function;
- drug, substance, or alcohol addiction;
- those participating in research involving invasive or non-invasive brain stimulation;
- those deemed unsuitable for MRI or tDCS after evaluation by the attending physician;
- those affiliated with any research-conducting institution.
Inclusion Criteria: Part 2: patients with chronic subcortical stroke
- aged between 40 and 80 years old;
- intact cognitive function (MMSE ≥ 27);
- first-ever onset of subcortical stroke occurring at least 3 months prior to enrollment, with brain lesions involving unilateral subcortical regions only;
- hemiplegic or hemiparetic;
- no spatial neglect;
- able to actively perform at least 5 degrees of ankle dorsiflexion and 10 degrees of ankle plantarflexion with the affected ankle;
- no excessive spasticity;
- no severe contracture (passive range of motion ≥ 10 degrees for ankle dorsiflexion and ≥ 20 degrees for ankle plantarflexion) in the affected leg;
- mild-to moderate disability;
- can walk independently or under supervision without assistance;
- corrected far vision ≥ 0.8 (Landolt C test) and uncorrected near vision ≥ 0.04 (Comprehensive Color Blindness Checklist.)
Exclusion Criteria: Part 2: patients with chronic subcortical stroke The exclusion criteria will be the same as those listed for healthy participants described in Part 1 except for items (3) and (4). Item (3) will be changed to "(3a) symptoms or history of other neurological diseases, including epilepsy, history of abnormal EEG, meningitis, encephalitis, brain tumors, brain surgery, and sensory disorders, etc." and item (4) will be changed to "(4a) severe musculoskeletal problems of the non-hemiparetic limbs that would affect mobility functions".
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
School and Graduate Institute of Physical Therapy, National Taiwan University
Taipei, 100
Pei-Fang Tang, PhD, +886 33668128, pftang@ntu.edu.tw
About this study
Official title: Investigating the Effects of Transcranial Direct Current Stimulation (tDCS) to Different Brain Regions on Ankle Tracking Motor Learning, Motor Adaptation, and Brain Connectivity in Healthy Middle-aged and Older Adults and Patients With Subcortical Stroke
Ankle control is essential to safe over-ground navigation for humans. Middle- aged and older adults and patients with stroke whose ankle control is poor often lose their balance or fall. Transcranial direct current stimulation (tDCS) is an emerging non-invasive brain stimulation technology that has great potential to be applied to neurorehabilitation; however, the optimization of its applications still needs further studies. The aims of this project are to compare the effects of anodal tDCS (AtDCS) applied to the primary motor cortex (M1) contralateral to the moving leg (cM1), posterior parietal cortex (PPC) contralateral to the moving leg (cPPC), and cerebellar cortex (CBM) ipsilateral to the moving leg (iCBM) on motor learning, motor adaptation, and brain connectivity in healthy middle-aged and older adults and hemiparetic patients with chronic subcortical stroke.
- Conditions
- Transcranial Direct Current Stimulation, Ankle, Motor Learning, Adaptation, Brain Structure, Brain Connectivity
- Being tested
- cM1 transcranial direct current stimulation, cPPC transcranial direct current stimulation, iCBM transcranial direct current stimulation, sham transcranial direct current stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cM1 transcranial direct current stimulationOther
During the 5-day skill acquisition phase, all participants will undertake a 20-minute session of learning a sequential ankle tracking task with their non-dominant (for healthy adults) or affected (for patients with stroke) foot each day, using a custom-built ankle tracking system. The cM1 group will receive AtDCS stimulation at 2 mA during acquisition phase.
cPPC transcranial direct current stimulationOther
During the 5-day skill acquisition phase, all participants will undertake a 20-minute session of learning a sequential ankle tracking task with their non-dominant (for healthy adults) or affected (for patients with stroke) foot each day, using a custom-built ankle tracking system. The cPPC group will receive AtDCS stimulation at 2 mA during acquisition phase.
iCBM transcranial direct current stimulationOther
During the 5-day skill acquisition phase, all participants will undertake a 20-minute session of learning a sequential ankle tracking task with their non-dominant (for healthy adults) or affected (for patients with stroke) foot each day, using a custom-built ankle tracking system. The iCBM group will receive AtDCS stimulation at 2 mA during acquisition phase.
sham transcranial direct current stimulationOther
For the Sham group, the montages of the paired electrode placements will be randomly selected from the other three pairs using blocks of size 3, so that the three types of montages will have equal opportunities to be used in the Sham group. The intensity will be set at 0 mA for the Sham group. There will be a 30-second ramp-up for the Sham group. Once the current reaches 2 mA in the ramp-up period, it will drop to 0 mA for the entire 20 minutes during learning for the Sham group.
| Study group | Role | What they receive |
|---|---|---|
| cM1 stimulation group | Experimental | cM1= primary motor cortex (M1) contralateral to the moving leg Receives: Other: cM1 transcranial direct current stimulation |
| cPPC stimulation group | Experimental | cPPC= posterior parietal cortex (PPC) contralateral to the moving leg Receives: Other: cPPC transcranial direct current stimulation |
| iCBM stimulation group | Experimental | iCBM= cerebellar cortex ipsilateral to the moving leg Receives: Other: iCBM transcranial direct current stimulation |
| Sham group | Sham comparator | Not described Receives: Other: sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mean RMSE value of ankle tracking performances
Using a custom-built ankle tracking system
Measured: 1 week
Change of Brain MRI data acquisition
Structural images: T1- and T2 weighted imaging, fluid attenuation inversion recovery (FLAIR) images, and diffusion spectrum image (DSI) Functional image: Resting-state functional MRI (rs-fMRI) images using a T2* gradient echo, echo-planar sequence.
Measured: 1 week
Secondary outcomes (7)
Fall histories
Fall Efficacy Scale (16~64 points, the higher score, the worsen outcome)
Measured: 1 week
Attention
language-free Color Trail Test- Part 1
Measured: 1 week
Muscle strength of bilateral ankle dorsiflexors and plantarflexors
Measured with a hand-held dynamometer
Measured: 1 week
Mobility
"Timed "Up and Go" test, four square step test
Measured: 1 week
Single-task gait
Measured with the GAITRite
Measured: 1 week
Sensory and motor functions of patients with stroke
Fugl-Meyer Assessment
Measured: 1 week
Balance
One-leg stance
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start9 Jul 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Fang Tang, PhD, Principal investigator, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556043
- Sponsor's protocol ID
- 202212150DINB
- Acronym
- tDCS
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Transcranial Direct Current Stimulation (tDCS) to Different Brain Regions on Ankle Tracking Motor Learning, Motor Adaptation, and Brain Connectivity in Healthy Middle-aged and Older Adults and Patients With Subcortical Stroke
- ClinicalTrials.gov ID
- NCT06556043
- Acronym / sponsor ID
- tDCS / 202212150DINB
- Conditions
- Transcranial Direct Current Stimulation, Ankle, Motor Learning, Adaptation, Brain Structure, Brain Connectivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 15 Aug 2024 (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.
Ankle control is essential to safe over-ground navigation for humans. Middle- aged and older adults and patients with stroke whose ankle control is poor often lose their balance or fall. Transcranial direct current stimulation (tDCS) is an emerging non-invasive brain stimulation technology that has great potential to be applied to neurorehabilitation; however, the optimization of its applications still needs further studies. The aims of this project are to compare the effects of anodal tDCS (AtDCS) applied to the primary motor cortex (M1) contralateral to the moving leg (cM1), posterior parietal cortex (PPC) contralateral to the moving leg (cPPC), and cerebellar cortex (CBM) ipsilateral to the moving leg (iCBM) on motor learning, motor adaptation, and brain connectivity in healthy middle-aged and older adults and hemiparetic patients with chronic subcortical stroke.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cM1 stimulation group | Experimental | Other: cM1 transcranial direct current stimulationcM1= primary motor cortex (M1) contralateral to the moving leg |
| cPPC stimulation group | Experimental | Other: cPPC transcranial direct current stimulationcPPC= posterior parietal cortex (PPC) contralateral to the moving leg |
| iCBM stimulation group | Experimental | Other: iCBM transcranial direct current stimulationiCBM= cerebellar cortex ipsilateral to the moving leg |
| Sham group | Sham comparator | Other: sham transcranial direct current stimulation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cM1 transcranial direct current stimulationDuring the 5-day skill acquisition phase, all participants will undertake a 20-minute session of learning a sequential ankle tracking task with their non-dominant (for healthy adults) or affected (for patients with stroke) foot each day, using a custom-built ankle tracking system. The cM1 group will receive AtDCS stimulation at 2 mA during acquisition phase. | Other | cM1 stimulation group |
| cPPC transcranial direct current stimulationDuring the 5-day skill acquisition phase, all participants will undertake a 20-minute session of learning a sequential ankle tracking task with their non-dominant (for healthy adults) or affected (for patients with stroke) foot each day, using a custom-built ankle tracking system. The cPPC group will receive AtDCS stimulation at 2 mA during acquisition phase. | Other | cPPC stimulation group |
| iCBM transcranial direct current stimulationDuring the 5-day skill acquisition phase, all participants will undertake a 20-minute session of learning a sequential ankle tracking task with their non-dominant (for healthy adults) or affected (for patients with stroke) foot each day, using a custom-built ankle tracking system. The iCBM group will receive AtDCS stimulation at 2 mA during acquisition phase. | Other | iCBM stimulation group |
| sham transcranial direct current stimulationFor the Sham group, the montages of the paired electrode placements will be randomly selected from the other three pairs using blocks of size 3, so that the three types of montages will have equal opportunities to be used in the Sham group. The intensity will be set at 0 mA for the Sham group. There will be a 30-second ramp-up for the Sham group. Once the current reaches 2 mA in the ramp-up period, it will drop to 0 mA for the entire 20 minutes during learning for the Sham group. | Other | Sham group |
Primary outcome
Change of mean RMSE value of ankle tracking performances
Time frame: 1 week
Using a custom-built ankle tracking system
Change of Brain MRI data acquisition
Time frame: 1 week
Structural images: T1- and T2 weighted imaging, fluid attenuation inversion recovery (FLAIR) images, and diffusion spectrum image (DSI) Functional image: Resting-state functional MRI (rs-fMRI) images using a T2* gradient echo, echo-planar sequence.
7 secondary outcomes
Fall histories
Time frame: 1 week
Attention
Time frame: 1 week
Muscle strength of bilateral ankle dorsiflexors and plantarflexors
Time frame: 1 week
Mobility
Time frame: 1 week
Single-task gait
Time frame: 1 week
Sensory and motor functions of patients with stroke
Time frame: 1 week
Balance
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Transcranial Direct Current Stimulation
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Enrolling by invitation
Brain Stimulation Paired With Structured Language Learning in Adults
Language Development, Learning
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.
Pei-Fang Tang, PhD principal investigator
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cM1 transcranial direct current stimulation, cPPC transcranial direct current stimulation and iCBM transcranial direct current stimulation in people with Transcranial Direct Current Stimulation and Ankle, 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?
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: status not confirmed, as of the sponsor's last update on 19 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Fang Tang, PhD (+886 33668128, pftang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mean RMSE value of ankle tracking performances (time frame: 1 week). 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 19 Aug 2024.