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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

ConditionsTranscranial Direct Current StimulationAnkleMotor LearningAdaptationBrain StructureBrain ConnectivityStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • cM1 transcranial direct current stimulation

    Other intervention

    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 stimulation

    Other intervention

    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 stimulation

    Other intervention

    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 stimulation

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: cM1 stimulation groupExperimental treatment 1 intervention
Group B: cPPC stimulation groupExperimental treatment 1 intervention
Group C: iCBM stimulation groupExperimental treatment 1 intervention
Group D: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of mean RMSE value of ankle tracking performances

Using a custom-built ankle tracking system

Time frame
1 week
2

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.

Time frame
1 week

Secondary outcomes

1

Fall histories

Fall Efficacy Scale (16\~64 points, the higher score, the worsen outcome)

Time frame
1 week
2

Attention

language-free Color Trail Test- Part 1

Time frame
1 week
3

Muscle strength of bilateral ankle dorsiflexors and plantarflexors

Measured with a hand-held dynamometer

Time frame
1 week
4

Mobility

"Timed "Up and Go" test, four square step test

Time frame
1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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