Ipsihand Device Use in Stroke Patients to Assess Motor Recovery of the Upper Extremity and Functional Outcomes
Phase: NA
Conditions: Stroke
Sponsor: Neurolutions, Inc.

IpsiHand Device Use in Stroke Patients to Assess Functional Motor
Outcomes
ClinicalTrials.gov Identifier:  NCT04338971
Date: July 20, 2020
Page 1 of 6

Study Protocol
The study is a prospective, non randomized, self controlled study performed in two phases
across two investigational sites. The study protocol allowed for a total completion of up to 20
adult subjects (18-85 years of age) who is a chronic stroke survivor of 6 months or more post
stroke. Subject must have residual hemiparesis in the upper extremity.
To be included in this study, subjects completed screening assessments to ensure subjects had
intact cognition to follow directions, intact vision without visual-spatial neglect, and motor
screening to ensure no contractures were present, to ensure the device would fit safely and
comfortably. If criteria was met, subjects would progress to Phase 1.
Phase 1 required subjects to complete EEG screenings to ensure an EEG signal was present and
adequate to control the opening and closing of the robotic hand exoskeleton. Should an
adequate EEG signal be present, subjects would progress to Phase 2.
Phase 2, A clinical specialist completed baseline motor evaluations were completed, and  each
subject  received skilled training with an IpsiHand Handpiece. The primary outcome measure
used in this study was the Fugl-Meyer Assessment - Upper Extremity. The clinical specialist
provided full training and skilled education regarding the set-up, management, and use of the
Neurolutions IpsiHand System for home therapy.  The Clinical Specialist educated each subject
concerning how to use the EEG signals to control the IpsiHand Handpiece, and how to clean and
store the device when not in use.  Each subject was given the opportunity to ask questions.
Each subject was instructed to use the Neurolutions IpsiHand System at home daily, for a use
target of one session, five (5) out of seven (7) consecutive days per week for a total of 12 weeks.
On each day of IpsiHand Therapy, the subjects completed up to five (5) 10-minute runs of the
cued task per day.  Each 10-minute run of the cued task consisted of 30 trials in which subjects
tried to open the exoskeleton by performing motor imagery and 30 trials, targeting to achieve a
minimum of 150 repetitions per day. Figure 1 shows the sequence of timepoints.
Date: July 20, 2020
Page 2 of 6

Figure 1: Study Timeline
Motor evaluations occurred by clinical specialists specifically trained to administer the Fugl-Meyer
Assessment - Upper Extremity. These motor evaluations occurred before receiving IpsiHand
training (Baseline), 4-week, 8-week and 12-week timepoints. The primary measure of statistical
success was the Fugl-Meyer. The Fugl-Meyer Assessment of the Upper Extremity was used to
assess the impact of the device in improving upper limb motor function and served as the primary
measure of statistical success, as determined by using a two-sided one-sample t-test, assuming a
normal distribution of scores. The Fugl-Meyer Assessment of the Upper Extremity was selected
as the primary measure of statistical success based on FDA guidance and increased sensitivity of
t1he measure, with a reduced floor effect as compared to the Action Research Arm Test (ARAT).
Statistical Methods
This study tested whether the Neurolutions System provides rehabilitative benefits for stroke
survivors.  The central hypotheses are that ipsilateral motor signals from the unaffected
hemisphere in chronic stroke survivors can be used to control a BCI system and furthermore, that
use of the Neurolutions IpsiHand System will enhance functional recovery through endogenous
plasticity
A two-sided, one-sample t-test, examining the change in motor function from baseline to study
completion, was used to evaluate the statistical significance (alpha = 0.05) of UEFM changes.
In addition to statistical analysis, the data was evaluated for clinical significance by utilizing
established Minimal Clinically Important Difference (MCID) scores for the UEFM.  The MCID has
been defined as an increase of 5.25 points from baseline in those with minimum to moderate
hemiparesis in the chronic phase (>=6 months) of stroke.
Study Sites
The study locations  were St. Louis, MO and Santa Cruz, CA.
Principal Investigator
The principal investigator was Alexandre Carter, MD, PhD.
Date: July 20, 2020
Page 3 of 6