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

NCT ID: NCT06556043

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-09
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

cM1 stimulation group

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

Group Type: EXPERIMENTAL

cM1 transcranial direct current stimulation

Intervention Type: 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 stimulation group

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

Group Type: EXPERIMENTAL

cPPC transcranial direct current stimulation

Intervention Type: 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 stimulation group

iCBM= cerebellar cortex ipsilateral to the moving leg

Group Type: EXPERIMENTAL

iCBM transcranial direct current stimulation

Intervention Type: 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 group

Group Type: SHAM_COMPARATOR

sham transcranial direct current stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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)

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

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-Fang Tang, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Pei-Fang Tang, PhD

Role: CONTACT

pftang@ntu.edu.tw

+886 33668128

Facility Contacts

Pei-Fang Tang, PhD

Role: primary

pftang@ntu.edu.tw

+886 33668128

Other Identifiers

202212150DINB

Identifier Type: -

Identifier Source: org_study_id