Clinical trial NCT06191549: Brain Stimulation Enhance Post-stroke Walking Survivors and Healthy Adults
Official title: Effect of Brain Stimulation on Locomotor Skill Acquisition in Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Vascular Accident
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: The Claude D. Pepper Older Americans Independence Centers
First posted: 2024-01-05
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.
Primary purpose: TREATMENT

Brief summary: Recent studies showed that a non-invasive, low-intensity brain stimulation called transcranial direct current stimulation (tDCS) can effectively increase motor neuron excitability in the brain and therefore promotes functional recovery after stroke. Thus, the overall purpose of this research project is to examine the effect of brain stimulation on motor skill learning in stroke survivors.

Detailed description: The specific aims and hypotheses are:

Aim 1: To explore the trends of locomotor skill acquisition in stroke survivors after anodal tDCS (a-tDCS, real brain stimulation), stroke survivors after sham tDCS (s-tDCS), and stroke with no brain stimulation (control; CON). Hypothesis (Aim 1): Stroke participants who receives a-tDCS will show a faster rate of learning a locomotor task compared to stroke participants who receive s-tDCS and stroke participants with no brain stimulation.

Aim 2: To explore different trends of stimulation-induced improvements in learning capacity and neural activities between three groups: stroke group, healthy young group, and healthy older group. Hypothesis (Aim 2): Healthy young adults will have a greater degree of stimulation-induced improvements in learning capacity and neural excitation compared to older adults and stroke participants.

Aim 3: To explore the trends of functional improvements post a-tDCS in stroke survivors. Hypothesis (Aim 3): Stroke participants who receives a-tDCS will show a greater improvements in functional performances compared to stroke participants who receive s-tDCS and stroke participants with no brain stimulation.

Aim 4: To explore the accumulated, longitudinal trends of a four-week visuomotor stepping training in conjunction with brain stimulation on treadmill walking training and gait improvements for persons with chronic stroke. Hypothesis (Aim 4): Stroke participants who receives a-tDCS will show a greater degree of gait improvements compared to stroke participants who receive s-tDCS and stroke participants with no brain stimulation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Mean change from baseline in stepping motor control after a single brain stimulation and locomotor learning session.
timeFrame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session
measure: Mean change from baseline in gait performances after a single brain stimulation and locomotor learning session.
timeFrame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session
measure: Mean change from baseline in brain neuronal network activations after a single brain stimulation and locomotor learning session.
timeFrame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session
measure: Mean change from baseline in brain neuronal activations after a single brain stimulation and locomotor learning session.
timeFrame: 0 minute, 30 minutes, and 24 hours a single brain stimulation session
measure: Mean change from baseline in stepping motor control after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training
timeFrame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training
measure: Mean change from baseline in gait performances after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training
timeFrame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training
measure: Mean change from baseline in brain neuronal network activations after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training
timeFrame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training
measure: Mean change from baseline in brain neuronal activations after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training
timeFrame: Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Shih-Chiao Tseng, PhD
role: PRINCIPAL_INVESTIGATOR
References: