Brain-Activated Therapy For Stroke Recovery

Clinical Evidence

The Neurolutions System has been evaluated in 40 subjects across three separate clinical studies (described below), all of which evaluated use of the Neurolutions system in chronic stroke survivors. All three studies were designed to determine the feasibility of recording electroencephalogram (EEG) signals from the affected and/or unaffected brain hemispheres, and to use the signals to control a computer to facilitate movement of a robotic hand orthosis (Handpiece).
The results of the studies have been analyzed to determine if the Neurolutions System can be used to positively impact rehabilitation. These three studies were open-label studies whereby a literature meta-analysis assessing usual care as well as minimal clinically important difference (MCID) benchmarks were utilized for comparison of device effectiveness in lieu of randomized control data.

Results of testing demonstrate that following 12 weeks of use of the Neurolutions System, chronic stroke survivors showed increases in the mean change from their baseline scores on the primary outcome measure for the three respective studies.
Ten of the total 40 subjects were assessed utilizing the Action Research Arm Test (ARAT) as the primary outcome measure and the mean scores exceeded the Minimal Clinically Important Difference (MCID) of 5.7 points (study QRS-0008). In the two other studies (QRS-0012 and QRS-0013), 30 of the total 40 subjects were assessed utilizing the Fugl-Meyer Upper Extremity (UEFM) assessment as the primary outcome measure. For 66.7% of these 30 subjects, mean scores exceeded the MCID of 5.25 points.
Overall, ARAT data were collected on a total of 27 subjects from QRS-0008 and QRS-0012 (ARAT was a secondary measure in QRS-0012), while UEFM data were collected in 30 subjects from studies QRS-0012 and QRS-0013. The 17 subjects assessed with ARAT as a secondary measure in QRS-0012, while demonstrating some mean improvement, did not exceed MCID. No patient injury or adverse events occurred in any of the studies.

FDA Cleared Class II Medical Device

The FDA designated IpsiHand as a breakthrough technology for chronic stroke rehabilitation.
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The FDA assessed the safety and effectiveness of the IpsiHand System device through clinical data submitted by the company, including an unblinded study of 40 patients over a 12-week trial. All participants demonstrated motor function improvement with the device over the trial. Adverse events reported included minor fatigue and discomfort and temporary skin redness.
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The IpsiHand System device should not be used by patients with severe spasticity or rigid contractures in the wrist and/or fingers that would prevent the electronic hand brace from being properly fit or positioned for use or those with skull defects due to craniotomy or craniectomy.
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The IpsiHand System device was granted Breakthrough Device designation, which is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
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The FDA reviewed the IpsiHand System device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing.
When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.