Helius Medical Technologies said today that clinical data from a multiple sclerosis pilot study of its portable neuromodulation stimulator was published in the Multiple Sclerosis Journal: Experimental, Translational and Clinical.
The company’s PONS system is designed to treat neurological symptoms, caused by trauma or disease, non-invasively through the tongue.
Helius’ pilot study evaluated its PONS device combined with intensive cognitive and physical rehabilitation on working memory, gait, balance and concomitant changes in the brains of patients with MS. The study enrolled 14 patients – 7 used the PONS device and 7 received a sham stimulation. For 14 weeks, patients underwent functional-MRI, motor performance measures and sensory organization tests before and after intense physical therapy and working memory training.
The group that used the PONS system showed significant improvement in sensory organization tests and functional-MRI showed signficiant blood oxygen level-dependent signal changes in the left primary motor cortex. The control group had increased activity in bilateral premotor corices, the authors wrote.
While all participants improved on working-memory tasks, the group that received Helius’ stimulator showed increased dorsolateral prefrontal cortex activity.
The authors concluded that in this group of MS patients, the PONS system enhanced motor performance and working memory, while also encouraging neuroplasticity.
“We would like to thank Drs. Leonard, Ptito and their team at the Montreal Neurological Institute for their work on this important study and congratulate them on this peer reviewed publication,” Helius’ chief medical officer Dr. Jonathan Sackier said in prepared remarks. “Understanding the additional, positive effects we are seeing with the investigational PoNS therapy compared to physiotherapy alone, is core to our clinical development. This publication should prove insightful to two key care givers, the physician and the therapist.”
In November, Helius said it expanded a source cost sharing contract with the U.S. Army Medical Research and Materiel Command.
The contract extension pushed the ending date to Dec. 31 this year and allows for additional study sites in a trial testing the use of the PONS device for chronic balance deficits in patients with mild to moderate traumatic brain injury.
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