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Purpose

This research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke.

Condition

Eligibility

Eligible Ages
Between 21 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Age between 21 and 90 years 2. Medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment 3. MRI or CT evidence from the imaging report shown that the stroke involves the corticospinal tract 4. Hemiparesis involving the lower extremity (Fulg-Meyer LE motor test) 5. No passive range of motion limitation in bilateral hips and knees 6. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less 7. Visual acuity can be corrected by glasses or contact lens to 20/20 8. Able to walk independently with/without assistant devices for 10 meters 9. Able to maintain standing position without any assistance > 30 sec (Short Physical Performance Battery) 10. Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24

Exclusion Criteria

  1. Pregnant women 2. MRI or CT evidence of involvement of the basal ganglia or cerebellum, evidence of multiple lesions, or evidence of any other brain damage or malignant neoplasm or tumors 3. Have any metal implants, cardiac pacemakers, or history of seizures 4. Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training 5. Any vestibular dysfunction or unstable angina 6. Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia*

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Explore the effects of brain stimulation on locomotor skill learning in stroke survivors 		To explore the trends of locomotor skill learning in three groups: stroke survivors after five sessions of anodal tDCS (a-tDCS, real brain stimulation), stroke survivors after five sessions of sham tDCS (s-tDCS), and stroke survivors with no brain stimulation (control; CON).
  • Combination Product: anodal transcranial direct current stimulation (a-tDCS)
    Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Stroke participants in the first two groups will receive five sessions of the assigned brain stimulation combined with visuomotor stepping training over five consecutive days. Healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.
Experimental
determine the effects of a-tDCS on the cortical excitation before and after locomotor learning 		measure changes in cortical neuronal activation before and after five sessions of locomotor skill training in healthy adults and stroke participants.
  • Combination Product: anodal transcranial direct current stimulation (a-tDCS)
    Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Stroke participants in the first two groups will receive five sessions of the assigned brain stimulation combined with visuomotor stepping training over five consecutive days. Healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.
Experimental
To explore improvements in learning capacity between healthy adults and stroke participants. 		Compare stimulation-induced improvements in learning capacity between three groups: stroke group, healthy young group, and healthy older group.
  • Combination Product: anodal transcranial direct current stimulation (a-tDCS)
    Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Stroke participants in the first two groups will receive five sessions of the assigned brain stimulation combined with visuomotor stepping training over five consecutive days. Healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.
Experimental
To explore the trends of functional improvements after five tDCS session in stroke survivors 		Compare functional improvements (gait performance, balance, motor and cognitive function) between healthy adults and stroke participants after five sessions of brain stimulation.
  • Combination Product: anodal transcranial direct current stimulation (a-tDCS)
    Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Stroke participants in the first two groups will receive five sessions of the assigned brain stimulation combined with visuomotor stepping training over five consecutive days. Healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.

Recruiting Locations

Physical Therapy, University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Shih-Chiao Tseng, PT, PhD
409-772-9555
shtseng@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Shih-Chiao Tseng, PT, PhD
409--772-9555
shtseng@utmb.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.