New tES System Gets Breakthrough Designation in Refractory Focal Epilepsy


The FDA breakthrough device designation follows a pilot study where patients showed a 44% median reduction in seizures when treated with Neuroelectrics’ transcranial electrical stimulation platform.

Alexander Rotenberg, MD, PhD, professor of neurology, Boston Children’s Hospital and Harvard Medical school

Alexander Rotenberg, MD, PhD

Neuroelectrics’ Starstim device has been granted FDA breakthrough device designation to treat refractory focal epilepsy, following pilot study results that showed a significant reduction in seizure frequency with its use. The neuromodulation platform was used to treat 20 patients with transcranial electrical stimulation (tES). 

The FDA’s decision follows results from the company’s latest nonrandomized, open-label, feasibility study, which included both adult and pediatric patients (over the age of 9 years) with medically refractory focal epilepsy. Investigators found that patients experienced 44% less seizures when following up after 8 weeks of treatment with the neuromodulation platform. Additionally, relative to baseline, 4 patients saw greater than 75% reduction in seizure frequency after being treated with the Starstim device.

“We are excited to receive the FDA breakthrough device designation for our lead program in refractory focal epilepsy,” Ana Maiques, cofounder and CEO, Neuroelectrics, said in a statement. “We hope that it will speed the evaluation of a new therapeutic modality that could potentially help patients who currently have no effective treatments available.”1 

The treatment was administered to participants over 10 sessions for a 2-week period. Evaluations were given at baseline and at the 8-week mark, as well as during the stimulation sessions. The device employs a cloud-based mechanism, allowing treatment to occur anywhere, and treatment protocols are created thanks to personalized brain models. 

“We are encouraged by the pilot study results, specifically by seizure suppression in patients whose seizures have not been controlled by drugs or surgery,” principal investigator Alexander Rotenberg, MD, PhD, said in a statement.1 “An effective noninvasive and nonpharmacologic antiseizure treatment option should improve our patients’ well-being and quality of life.”

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Rotenberg, professor of neurology at Boston Children’s Hospital and Harvard Medical school, will now lead a pivotal study for Neuroelectrics to further evaluate safety and efficacy of the Starstim device. The multiple-site, randomized, double blinded parallel-group controlled study will divide 190 participants into treatment or sham groups.

Transcranial magnetic stimulation (TMS) and cathodal transcranial direct current stimulations (tDCS) are both noninvasive neurostimulation techniques, with the latter being used in the pilot study to determine its effect on seizure frequency compared to baseline. Used to incite underlying cortical excitability, tDCS emits a 1-2 mA unidirectional electrical current to the scalp of patients. 

In addition to treating refractory focal epilepsy, TMS has previously been used in screenings for mild cognitive impairment (MCI) and to differentiate dementias, all noninvasively. A study earlier this year evaluated a random forest classifier on TMS in patients with MCI, with researchers employing a series of 3 binary classifiers, all of which resulted in high classification accuracy (range, 0.72-0.86), high precision (range, 0.72-0.90), high recall (range, 0.75-0.98) and high F1-scores (range, 0.78-0.92) in differentiation of neurodegenerative disorders. When a new classifier, trained and validated on the cohort of patients with MCI, was used, classification indices showed higher accuracy (range, 0.83-0.93), precision (range, 0.87-0.89), recall (range, 0.83-1.00), and F1 scores (range, 0.85-0.94).2

1. Neuroelectrics granted FDA breakthrough device designation for new therapeutic neuromodulation platform to treat refractory focal epilepsy. News release, Neuroelectrics. June 30, 2021. Accessed July 13, 2021.
2. Benussi A, Grassi M, Palluzzi F, et al. Classification accuracy of TMS for the diagnosis of mild cognitive impairment. Brain Stimul. 2021;14(2):241-249. doi:10.1016/j.brs.2021.01.004
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