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NCT Number: NCT06556043

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Pei-Fang Tang, PhD

CONTACT

[email protected]

+886 33668128

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

cM1 transcranial direct current stimulation

Other

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

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

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

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.

Primary outcomes

  1. Change of mean RMSE value of ankle tracking performances

    Time frame: 1 week

    Using a custom-built ankle tracking system

  2. 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.

Secondary outcomes

  1. Fall histories

    Time frame: 1 week

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

  2. Attention

    Time frame: 1 week

    language-free Color Trail Test- Part 1

  3. Muscle strength of bilateral ankle dorsiflexors and plantarflexors

    Time frame: 1 week

    Measured with a hand-held dynamometer

  4. Mobility

    Time frame: 1 week

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

  5. Single-task gait

    Time frame: 1 week

    Measured with the GAITRite

  6. Sensory and motor functions of patients with stroke

    Time frame: 1 week

    Fugl-Meyer Assessment

  7. Balance

    Time frame: 1 week

    One-leg stance

Study contacts

Contact information is provided by the study sponsor or research team.

Pei-Fang Tang, PhD

CONTACT

[email protected]

+886 33668128

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Acronym: tDCS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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