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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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06556043
Acronym
tDCS
Enrollment
120
Registered
2024-08-15
Start date
2024-07-09
Completion date
2026-07-31
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adaptation, Ankle, Brain Connectivity, Brain Structure, Motor Learning, Stroke, Transcranial Direct Current Stimulation

Brief 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. 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.

Interventions

OTHERcM1 transcranial direct current stimulation

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.

OTHERcPPC transcranial direct current stimulation

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.

OTHERiCBM transcranial direct current stimulation

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.

OTHERsham transcranial direct current stimulation

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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Part 1: healthy middle-aged and older adults 1. age between 40 and 80 years old 2. intact cognitive function (MMSE ≧ 27) 3. normal ankle dorsiflexor and plantarflexor strength (manual muscle strength testing= 5) and passive range of motion (ankle dorsiflexion ≧10 degrees; ankle plantarflexion ≧ 45 degrees) 4. 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 1. having any contraindications for MRI or tDCS; 2. serious or uncontrolled systematic diseases; 3. 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.; 4. severe musculoskeletal problems that would affect lower limb functions; 5. visual spatial perception disorders and hearing loss; 6. color blindness; 7. depression and psychiatric disorders; 8. use of any medication that could affect the central nervous system function; 9. drug, substance, or alcohol addiction; 10. those participating in research involving invasive or non-invasive brain stimulation; 11. those deemed unsuitable for MRI or tDCS after evaluation by the attending physician; 12. those affiliated with any research-conducting institution. Inclusion Criteria: Part 2: patients with chronic subcortical stroke 1. aged between 40 and 80 years old; 2. intact cognitive function (MMSE ≥ 27); 3. first-ever onset of subcortical stroke occurring at least 3 months prior to enrollment, with brain lesions involving unilateral subcortical regions only; 4. hemiplegic or hemiparetic; 5. no spatial neglect; 6. able to actively perform at least 5 degrees of ankle dorsiflexion and 10 degrees of ankle plantarflexion with the affected ankle; 7. no excessive spasticity; 8. no severe contracture (passive range of motion ≥ 10 degrees for ankle dorsiflexion and ≥ 20 degrees for ankle plantarflexion) in the affected leg; 9. mild-to moderate disability; 10. can walk independently or under supervision without assistance; 11. corrected far vision ≥ 0.8 (Landolt C test) and uncorrected near vision ≥ 0.04 (Comprehensive Color Blindness Checklist.)

Design outcomes

Primary

MeasureTime frameDescription
Change of mean RMSE value of ankle tracking performances1 weekUsing a custom-built ankle tracking system
Change of Brain MRI data acquisition1 weekStructural 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.

Secondary

MeasureTime frameDescription
Muscle strength of bilateral ankle dorsiflexors and plantarflexors1 weekMeasured with a hand-held dynamometer
Mobility1 weekTimed Up and Go test, four square step test
Fall histories1 weekFall Efficacy Scale (16\ 64 points, the higher score, the worsen outcome)
Sensory and motor functions of patients with stroke1 weekFugl-Meyer Assessment
Balance1 weekOne-leg stance
Single-task gait1 weekMeasured with the GAITRite
Attention1 weeklanguage-free Color Trail Test- Part 1

Countries

Taiwan

Contacts

Primary ContactPei-Fang Tang, PhD
pftang@ntu.edu.tw+886 33668128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026