Gait, Hemiplegic Clinical Trial
Official title:
Effect of Brain Stimulation on Motor Skill Acquisition in Stroke Survivors and Healthy Adults
Participants are being asked to participate in a research study conducted by Shih-Chiao
Tseng, PT, Ph.D. at Texas Woman's University. This research study is to determine whether
low-intensive brain stimulation can enhance learning of a leg movement task. The
investigators also want to know if brain stimulation can improve the nerve function and
walking performance. Our goal is to understand any relationship between brain stimulation and
overall movement control improvement. Participants have been invited to join this research if
they have had a stroke before or they are healthy adults aged 21 years or older. Research
evidence shows stroke can induce permanent brain damage and therefore may cause a person to
have trouble learning a new task. This in turn may significantly impact the recovery of motor
function in stroke survivors. In addition, the investigators also want to know how a healthy
person learns this new leg task and see if her/his learning pattern differs from a stroke
survivor.
This study comprises two phases: Phase I study investigates short-term effects of brain
stimulation on leg skill learning and only requires two visits to TWU. The total time
commitment for Phase I study will be about 6.5 hours, 3.5 hours on the first visit and three
hours on the second visit; Phase II study is an expanded version of Phase I study to
investigate long-term effects of brain stimulation on leg skill learning and requires to
complete 12 visits of exercise training paired with brain stimulation over a four-week period
and additional one visit for follow-up test. The total time commitment for Phase II study
will be about 20 hours, a total of 18 hours for 12 exercise training sessions and two hours
for a follow-up test. The investigators hypothesize that people with chronic stroke will show
a slower rate of acquiring this leg skill as compared to healthy adults. The investigators
also hypothesize that co-applying brain stimulation with 12 sessions of exercise training
will enhance skill learning of this leg task for people with chronic stroke and this
12-session exercise program may exert beneficial influences on the nerve function and leg
muscle activation, and consequentially improve motor control for walking.
This study will take place at Texas Woman's University (TWU)-Houston campus and include two
phases: Phase I involves a single-intervention study and Phase II involves a four-week
intervention study. After enrolling to the study, participants can choose to only participate
in the Phase I study or choose to participate in both Phase I and Phase II studies.
Phase I Study - participants will be asked to complete two visits, 1-14 days apart. It will
take about a total of 6.5 hours of their time to complete all tests (3.5 hours for the first
visit and 3 hours for the second visit, two visits). Participants will need to wear
short-sleeve t-shirt, shorts, and a pair of sneakers for testing. During the first visit, the
investigators will measure how well the nervous system works and how well the individual
walks (see details as follows). If participants have had a stroke before, on the first visit
the investigators will do some tests on to make sure participants have good feeling, balance,
and motor responses in their legs. If all tests are good, participants will fill out a form
asking about their medical history. If participants have not had a stroke, the investigators
will ask a few questions to make sure participants do not have any medical issues.
Next, the investigators will ask participants to learn a leg movement task at each visit. The
task is to control and move a computer cursor from a start location to one of three targets
displayed on the computer monitor. Participants will need to make forward, rightward or
leftward foot movements to guide the cursor to one of the targets. The task itself is similar
to the daily computer task performed by a hand mouse. In each visit, it will take
approximately a total of 45 minutes to complete a set of leg reaching task. Several
one-minute rest breaks will be provided as needed during test. Participants will then be
asked to come back for the second visit within 1-14 days later to repeat the same task.
Throughout practice, participants will learn how to control the cursor using their feet. So
the investigators can compare the learning capacity over two visits to best indicate the
change in the learning capacity over time.
The investigators also want to know if participants can learn this motor skill faster with
cutaneous brain stimulation. Participants will receive weak electrical brain stimulation for
20 minutes during leg skill learning. The brain stimulation device that the investigators
used is similar to the commercial product seen in the TV/magazine, called "transcutaneous
electrical Nerve stimulation" in which electrical current is delivered by electrodes for pain
relief and muscle stimulation. In this study, two electrodes, one placed on the top of the
scalp and one placed on the forehead, will deliver weak electrical current for 20 minutes.
Because the investigators set the current intensity at a very low level, it will not cause
any muscle twitches and participants may only feel little tingling sensation in the first 10
seconds. Most of the time, participants likely become accustomed to the stimulation and no
longer feel the stimulation throughout the rest of the session.
Phase II Study - This study is an expanded version of Phase I study. Participants will be
asked to complete 12 visits of exercise training paired with brain stimulation over a
four-week period. It will take about a total of 18 hours of the time to complete all training
sessions (1.5 hour for each visit/training for a total of 12 visits). Participants will need
to wear short-sleeve t-shirt, shorts, and a pair of sneakers for training. Before and after
four-week training, the investigators will measure how well the nervous system works and how
well the participant walks (see details as follows). One week after completion of four-week
training, participants will be asked to come back to repeat the same tests. The investigators
will compare changes in the learning capacity and motor function before and after four-week
training, and at one week after completion of training to best indicate permanent changes in
the learning capacity and motor function over time.
During each visit, the investigators will ask participants to continue learning a leg
movement task same as the Phase I study. The investigators will also ask participants to
learn a similar leg task, call stepping task during standing. This stepping task is very
similar to the leg task in the Phase I study, but is a more advanced task that requires a
good standing balance. The task is to control a computerized marker attached to the foot and
move a computer cursor from a start location to one of three targets displayed on the
computer monitor. Participants will need to make forward, rightward or leftward stepping
movements to guide the cursor to one of the targets. The task itself is similar to stepping
motion during walking. In each visit, it will take approximately a total of 1.5 hour to
complete two sets of leg task training during sitting and standing. Same brain stimulation
used in the Phase I study (see above) will be delivered during the middle of the exercise
training. Several one-minute rest breaks will be provided as needed during training.
Participants will then be asked to come to the laboratory three times per week for four weeks
in order to complete 12 training sessions.
Outcome measures - For the measurement of brain activity, the investigators will put a
recording electrode on the calf muscle in one leg. Five low-intensity brain stimulation will
be delivered to the scalp to trigger the motor responses. Most of the time, participants will
feel single muscle twitch due to the stimulation. It would take a total of 10 minutes to
finish data collection. For the measurement of nerve activity, the investigators will put a
recording electrode on the calf muscle in one leg. Low-intensity electrical stimulation will
be delivered to a nerve behind the knee to trigger motor responses. A series of small tendon
vibration stimuli will be delivered during electrical stimulation to determine the
sensitivity of the nerve. Most of the time, participants will feel nothing or just light
tingling sensation in the stimulated area. It would take a total of 40 minutes to finish data
collection. Several one-minute rest breaks will be provided as needed during test. For the
measurement of walking, the investigators will put sticky markers on both legs and ask
participants to walk normally across a 10-meter walkway for five trials. It would take
approximately a total of 30 minutes to finish data collection. Several one-minute rest breaks
will be provided as needed during test. For the stepping reaction time test, subjects will
stand on the force plates and will be instructed to step forward onto a target marked on the
floor as soon as they sense electrical stimulation delivered to the posterior of the leg. It
would take approximately a total of 40 minutes to finish data collection. Several one-minute
rest breaks will be provided as needed during test.
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