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 (tDCS)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Brain Connectivity; Transcranial Direct Current Stimulation; Motor Learning; Adaptation; Brain Structure; Ankle
• Intervention / Treatment: Other: cM1 transcranial direct current stimulation; Other: cPPC transcranial direct current stimulation; Other: iCBM transcranial direct current stimulation; Other: sham transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei-Fang Tang, PhD; Phone Number: +886 33668128; Email: pftang@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • School and Graduate Institute of Physical Therapy, National Taiwan University
    • Contact: Pei-Fang Tang, PhD; Phone Number: +886 33668128; Email: pftang@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.)

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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham group	Other: sham 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.
Experimental: cM1 stimulation group; cM1= primary motor cortex (M1) contralateral to the moving leg	Other: cM1 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.
Experimental: cPPC stimulation group; cPPC= posterior parietal cortex (PPC) contralateral to the moving leg	Other: cPPC 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.
Experimental: iCBM stimulation group; iCBM= cerebellar cortex ipsilateral to the moving leg	Other: iCBM 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention	language-free Color Trail Test- Part 1	1 week
Muscle strength of bilateral ankle dorsiflexors and plantarflexors	Measured with a hand-held dynamometer	1 week
Mobility	"Timed "Up and Go" test, four square step test	1 week
Single-task gait	Measured with the GAITRite	1 week
Sensory and motor functions of patients with stroke	Fugl-Meyer Assessment	1 week
Balance	One-leg stance	1 week
Fall histories	Fall Efficacy Scale (16~64 points, the higher score, the worsen outcome)	1 week

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Pei-Fang Tang, PhD, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 202212150DINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No