Explore the Effects of Cortical Priming on Visuomotor Stepping Learning in Persons With Chronic Stroke

The University of Texas System (UT)

Status: Enrolling

Conditions: Stroke

Treatments: Combination Product: anodal transcranial direct current stimulation (a-tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06681207

24-0234

Details and patient eligibility

About

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

Enrollment: 108 estimated patients

Sex: All

Ages: 21 to 90 years old

Volunteers: Accepts Healthy Volunteers

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*

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 4 patient groups

Explore the effects of brain stimulation on locomotor skill learning in stroke survivors

Experimental group

Description:

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).

Treatment:

Combination Product: anodal transcranial direct current stimulation (a-tDCS)

determine the effects of a-tDCS on the cortical excitation before and after locomotor learning

Experimental group

Description:

measure changes in cortical neuronal activation before and after five sessions of locomotor skill training in healthy adults and stroke participants.

Treatment:

Combination Product: anodal transcranial direct current stimulation (a-tDCS)

To explore improvements in learning capacity between healthy adults and stroke participants.

Experimental group

Description:

Compare stimulation-induced improvements in learning capacity between three groups: stroke group, healthy young group, and healthy older group.

Treatment:

Combination Product: anodal transcranial direct current stimulation (a-tDCS)

To explore the trends of functional improvements after five tDCS session in stroke survivors

Experimental group

Description:

Compare functional improvements (gait performance, balance, motor and cognitive function) between healthy adults and stroke participants after five sessions of brain stimulation.

Treatment:

Combination Product: anodal transcranial direct current stimulation (a-tDCS)