Results of the study will be presented in an oral session at the International Conference for Innovation in Angio-Neurology held in Moscow on September 23-24, 2016, a gathering of more than 500 neurologists, neurosurgeons, trauma doctors and other healthcare practitioners.
The PoNS™ is an investigational device that is currently in clinical development in the United States and has not been cleared for commercial distribution.
This 65-subject (45-active, 20 control) study included children (ages 3-13) with Gross Motor Function Classification Scores (GMFCS) ranging from II-IV*.
All subjects received 10-days of standard physiotherapy and movement control therapy with the active group receiving 20-25 minutes of concomitant electro-lingual neurostimulation with PoNS™. Primary outcomes were scored by Ashworth Scale (spasticity), Berg Scale (Balance) and GMFCS.
Secondary measures included preferred walking speed, step length, lower extremity strength and quality of life measures. Statistically significant differences in spasticity (p< 0.005) and lower limb gross motor function (p<0.00001) were reported in favor of the active group.
Positive changes in quality of life, cognitive function, and social status were also observed. The researchers concluded facilitation of physiotherapy with the PoNS™ device can improve motor control in patients with CP.
"We are delighted that independent research continues to support a growing belief in the potential benefits of PoNS™ therapy for an expanding spectrum of disease states," said Jonathan Sackier, Chief Medical Officer, Helius Medical Technologies.
The PoNS™ device is an investigational non-invasive method to deliver neurostimulation through the tongue.
PoNS™ Therapy combines the use of the device with physiotherapy and is currently being evaluated in a pivotal, multicenter, clinical trial for the treatment of balance disorder in subjects with mild to moderate Traumatic Brain Injury (TBI).
The PoNS ™ Therapy is also being evaluated in the treatment of symptoms related to other neurologic diseases including Multiple Sclerosis and Cerebral Palsy.
