Nexstim Progresses its Navigated Brain Stimulation Technology in Stroke and Demonstrates Improved Outcomes in Brain Tumor Surgery
28 August 2014
* Study on track and sites selected and initiated in multicenter clinical trial on the therapeutic effects of NBT® for stroke rehabilitation
* Nexstim´s NBS® motor mapping in neurosurgical planning improves outcomes of brain tumor surgery
HELSINKI, Finland--Aug. 28, 2014--Nexstim (the "Company"), a medical technology company focused on Navigated Brain Stimulation, announces that selection and initiation at all of the sites is now complete for its multicenter clinical trial on the therapeutic effects of Nexstim´s Navigated Brain Therapy (NBT®) for stroke rehabilitation and that the study is progressing to plan and enrolling patients. The Company also announces the publication of two key papers reporting significant improvements in patient outcomes after starting to use Nexstim´s Navigated Brain Stimulation (NBS®) motor mapping prior to surgery.
NBT® Stroke Rehabilitation Clinical Trial on Track
Nexstim began its clinical trial in June 2014 and the trial has now been fully initiated and enrollment has begun on schedule. The trial, so-called NICHE (Navigated Inhibitory rTMS in Contralesional Hemisphere Evaluation) is a multicenter, double-blinded, randomized, and sham-controlled trial to determine the therapeutic effects of NBT®, a navigated rTMS (repetitive transcranial magnetic stimulation) therapy, for post-acute stroke rehabilitation. In the trial, all patients will receive occupational therapy and on top of that they will receive either sham (placebo) or NBT®. NICHE will be conducted at twelve prominent rehabilitation sites in the United States and is expected to complete in 2016.
Nexstim launched the novel NBT® device in 2012 for the treatment of brain injury after stroke using rTMS guided by a patient´s own MRI-scan. Initial single-center and sham controlled data with NBT® demonstrated potential in helping stroke patients regain lost motor control. The NBT® System meets the requirements of the European Medical Devices Directive (MDD) and is CE-marked.
Janne Huhtala, Chief Executive Officer of Nexstim, commented: "We are delighted that Nexstim´s clinical trial on the therapeutic effects of NBT® for stroke rehabilitation is now fully enrolled with all sites operational and is progressing to plan. We are extremely excited by the potential of this therapy where there is currently no clinically effective treatment. This opportunity represents 270,000 new patients every year in the US alone and we have a new treatment method that could potentially mark a significant step forward for stroke rehabilitation globally."
Published outcome studies
NBS® motor mapping provides a valuable tool that allows surgeons to identify the maximum amount of safely resectable tissue prior to surgery.
Recently, two papers from two leading departments of neurosurgery at German University Hospitals have reported significant improvements in patient outcomes after using NBS® motor mapping. In total, 350 patients with brain tumors in the motor cortex have been mapped with NBS® and have been compared to 215 patients with similar tumors who have been operated on by the same teams immediately prior to NBS®.
In the paper published in Charite Berlin* (a study with 250 NBS® mapped patients and 115 controls), the key finding was that the rate of gross total resection (i.e. complete tumor removal) increased from 42% to 59% with NBS® (p<0.05, increase of 40%). In addition, progression free survival time in which no tumor growth is observed by post-operative imaging increased, especially in the patients with a low grade glioma (a slow growing tumor type), for which the increase was from 15.4 to 22.4 months (p<0.05, increase of 45%);
In the paper published by Technical University of Munich** (a study with 100 NBS® mapped patients and 100 controls), the findings were consistently positive for NBS®. Application of NBS® resulted in a statistically significantly increased rate of gross total resection (78% in NBS® group, 58% in control group, (OR 0.3828; 95% CI 0.2062-0.71072-0.7107), increase of 34%). In addition, the more extensive resections did not come at the expense of increasing neurological complications as the rate of new permanent post-operative neurological deficits was actually lower - although the difference was not statistically significant - in the NBS® group (13%) than in the control group (18%). However, use of NBS® was associated with improved outcomes of pre-surgical neurological deficits. Moreover, 12% of patients in NBS® and 1% in control group, p<0.01 experienced improvement of pre-existing neurological deficits after surgery.
Dr. Sujit Prabhu, MD, FRCS, FAANS, Associate Professor, Department of Neurosurgery, MD Anderson Cancer Center added: "These two publications clearly demonstrate the value of using NBS® motor mapping in planning surgery of eloquent area brain tumors. NBS® provides the neurosurgeon a new tool to identify the resectable tissue and plan the operation accordingly, as shown by the higher rates of gross total tumor resection without an increase in post-surgical complications. We are very excited of these findings which are changing neurosurgical clinical practice and improving outcomes of patients suffering from brain tumors."
Nexstim is a medical technology company focusing on improving rehabilitation for stroke patients. Nexstim has pioneered the technology for brain diagnostics with the Navigated Brain Stimulation (NBS®) System as the first and only FDA-cleared and CE-marked navigated Transcranial Magnetic Stimulation (nTMS) device for pre-surgical mapping of the motor and speech cortices. Based on the same technology platform the company has developed a device for stroke therapy, called Navigated Brain Therapy (NBT®). Nexstim has initiated a two-year pivotal Phase III study at 12 sites in the US aiming to demonstrate the effectiveness of NBT® and gain FDA approval for commercialization in post-acute stroke.
About Transcranial Magnetic Stimulation (TMS) and Repetitive Transcranial Magnetic Stimulation (rTMS)
Transcranial Magnetic Stimulation (TMS) is a noninvasive technique that consists of a magnetic field emanating from a wire coil held outside of the head. The magnetic field induces an electrical current in nearby regions of the brain. Repetitive Transcranial Magnetic Stimulation (rTMS) sends repetitive and focused stimulation to one region of the brain. rTMS is not used for motor mapping, it is used for FDA cleared speech and language mapping (NexSpeech®) and in clinical trials for therapies such as stroke.
About Navigated Brain Stimulation (NBS®)
Navigated Brain Stimulation NBS® is a noninvasive procedure providing an accurate and detailed map of the critical functions of the cortex. Through the use of a standard MRI brain scan, transcranial magnetic stimulation, and EMG, this procedure excites and records responses of precise areas of the cortex for use in diagnostic applications.
About Navigated Brain Therapy (NBT®)
Navigated Brain Therapy (NBT®) is a noninvasive system that uses navigation to accurately target therapy directly to the cortical structures believed to be involved in brain dysfunctions. The device is CE-marked for use in patients recovering from stroke as a supplement to conventional rehabilitation.
Please Note: Nexstim´s NBS® System is cleared by the FDA for assessment of the motor and speech cortices for pre-procedural planning. The NBT® System is not cleared for commercial distribution in the United States.
* Dietmar Frey, Peter Vajkoczy, and Thomas Picht Navigated transcranial magnetic stimulation improves the treatment outcome in patients with brain tumors in motor eloquent locations Neuro Oncology 2014 : nou110v1-nou110.
** Sandro M. Krieg, Preoperative motor mapping by navigated transcranial magnetic brain stimulation improves outcome for motor eloquent lesions Neuro Oncol first published online February 9, 2014 doi:10.1093/neuonc/nou007
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