Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Ankle
Motor Learning
Adaptation
Brain Structure
Brain Connectivity
Stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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".

Primary outcomes:
measure: Change of mean RMSE value of ankle tracking performances
timeFrame: 1 week
measure: Change of Brain MRI data acquisition
timeFrame: 1 week
Secondary outcomes:
measure: Fall histories
timeFrame: 1 week
measure: Attention
timeFrame: 1 week
measure: Muscle strength of bilateral ankle dorsiflexors and plantarflexors
timeFrame: 1 week
measure: Mobility
timeFrame: 1 week
measure: Single-task gait
timeFrame: 1 week
measure: Sensory and motor functions of patients with stroke
timeFrame: 1 week
measure: Balance
timeFrame: 1 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, National Taiwan University
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taiwan
name: Pei-Fang Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: