Brain Stimulation Enhance Post-stroke Walking Survivors and Healthy Adults

Effect of Brain Stimulation on Locomotor Skill Acquisition in Stroke

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Vascular Accident
• Intervention / Treatment: Combination product: anodal transcranial direct current stimulation (a-tDCS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shih-Chiao Tseng, PhD; Phone Number: 409-772-9555; Email: shtseng@utmb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: To explore the effect of brain stimulation on locomotor skill acquisition in stroke survivors; 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).	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). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups. Stroke participants in each group will receive a four-week of the assigned brain stimulation combined with visuomotor stepping training and treadmill training
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). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups. Stroke participants in each group will receive a four-week of the assigned brain stimulation combined with visuomotor stepping training and treadmill training
Experimental: To explore the trends of functional improvements after single a-tDCS session in stroke survivors.; To explore functional improvements (gait performance, brain neural activation) between a-tDCS, s-tDCS, and control groups.	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). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups. Stroke participants in each group will receive a four-week of the assigned brain stimulation combined with visuomotor stepping training and treadmill training
Experimental: To explore the accumulated effects of brain stimulation on gait improvements in stroke survivors; 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.	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). Young and older healthy adults will be randomly assignments into a-tDCS or s-tDCS groups. Stroke participants in each group will receive a four-week of the assigned brain stimulation combined with visuomotor stepping training and treadmill training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in stepping motor control after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training	stepping motor control will be quantified by the time (seconds) that each participant takes to initiate a forward step onto a visual target displayed on the wall screen	Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training
Mean change from baseline in gait performances after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training	Gait performances will be quantified by gait speeds (meters/second) during ground walking tests	Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training
Mean change from baseline in brain neuronal network activations after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training	The neuronal activations will be quantified by oxygen consumption changes locally detected by surface infrared diodes	Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training
Mean change from baseline in brain neuronal activations after a four-week brain stimulation combined with visuomotor stepping training and treadmill walking training	The neuronal activations will be quantified by peak-to-peak electrical signals detected by surface electromyographic (EMG) electrodes on leg muscles after transcranial magnetic stimulations	Day 1, Day 7, Day 30, Day 90 post a four-week brain stimulation combined with visuomotor stepping and treadmill walking training
Mean change from baseline in stepping motor control after a single brain stimulation and locomotor learning session.	stepping motor control will be quantified by the time (seconds) that each participant takes to initiate a forward step onto a visual target displayed on the wall screen	0 minute, 30 minutes, and 24 hours a single brain stimulation session
Mean change from baseline in gait performances after a single brain stimulation and locomotor learning session.	Gait performances will be quantified by gait speed (meters/second) during ground walking tests	0 minute, 30 minutes, and 24 hours a single brain stimulation session
Mean change from baseline in brain neuronal network activations after a single brain stimulation and locomotor learning session.	The neuronal activations will be quantified by oxygen consumption changes locally detected by surface infrared diodes.	0 minute, 30 minutes, and 24 hours a single brain stimulation session
Mean change from baseline in brain neuronal activations after a single brain stimulation and locomotor learning session.	The neuronal activations will be quantified by peak-to-peak electrical signals detected by surface electromyographic (EMG) electrodes on leg muscles after transcranial magnetic stimulations	0 minute, 30 minutes, and 24 hours a single brain stimulation session

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Shih-Chiao Tseng, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 21-0295

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No