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

NCT06556043 | Recruiting

• 1 other identifier: 202212150DINB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change of mean RMSE value of ankle tracking performances

  Using a custom-built ankle tracking system

  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.

  1 week

Secondary Outcomes (7)

• Fall histories

  1 week

• Attention

  1 week

• Muscle strength of bilateral ankle dorsiflexors and plantarflexors

  1 week

• Mobility

  1 week

• Single-task gait

  1 week

Study Arms (4)

cM1 stimulation group

EXPERIMENTAL

cM1= primary motor cortex (M1) contralateral to the moving leg

Other: cM1 transcranial direct current stimulation

cPPC stimulation group

EXPERIMENTAL

cPPC= posterior parietal cortex (PPC) contralateral to the moving leg

Other: cPPC transcranial direct current stimulation

iCBM stimulation group

EXPERIMENTAL

iCBM= cerebellar cortex ipsilateral to the moving leg

Other: iCBM transcranial direct current stimulation

Sham group

SHAM COMPARATOR

Other: sham transcranial direct current stimulation

Interventions

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.

cM1 stimulation group

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.

cPPC stimulation group

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.

iCBM stimulation group

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.

Sham group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pei-Fang Tang, PhD

  School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Fang Tang, PhD

CONTACT

+886 33668128; pftang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: August 15, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)