Nexstim Initiates Multicenter Clinical Trial on the Therapeutic Effects of Navigated TMS for Stroke Rehabilitation
June 11, 2014
ALPHARETTA, Ga. — Nexstim has launched a multicenter double-blinded, randomized, and sham-controlled trial to determine the therapeutic effects of navigated rTMS (repetitive transcranial magnetic stimulation) for stroke rehabilitation. This cutting-edge stroke therapy combines occupational therapy with nTMS (navigated transcranial magnetic stimulation). Called the NICHE trial (Navigated Inhibitory rTMS in Contralesional Hemisphere Evaluation), this two year study will be conducted at twelve of the top rehabilitation sites in the United States.
“The trial results are showing great potential for non-invasive brain modulation and the difference Nexstim is providing is the proven Navigation to enable this approach.” – Janne Huhtala, CEO, Nexstim
Dr. Richard Harvey, Medical Director, Center for Stroke Rehabilitation, Rehabilitation Institute of Chicago (RIC), developed the protocol with Nexstim and ran the single center trial. Dr. Harvey and his team at RIC presented the trial results at the American Heart Association’s International Stroke Conference in February, ‘The Contrastim Stroke Study: Improving Hand and Arm Function After Stroke with Combined Non-Invasive Brain Stimulation and Task-Oriented Therapy’ (presentation #152).
Dr. Harvey’s study approached stroke rehabilitation through a new combination of therapies which produced significantly greater gains in patients’ motor function 6 months post stroke. The combination of non-invasive navigated transcranial magnetic stimulation (nTMS) along with occupational therapy opened the door to improving the quality of life for stroke survivors. The study showed over 80% of the active group received a clinically meaningful response rate.
Researchers working at the following trial sites, will enroll up to 200 patients, and will look to replicate the initial findings.
Ranchos Los Amigos National Rehabilitation Institute
Ohio State University
University of Cincinnati
TIRR Memorial Hermann Hospital
About the Technology:
The NBS System uses stereotactic MRI-guided transcranial magnetic stimulation (TMS) to non-invasively modulate precise areas of the motor cortex. The system’s e-field based targeting tool allows the therapist to accurately locate the patients exact stimulation target using technology similar to mapping the globe with a GPS. The nTMS is used to stimulate the patient’s non-injured brain hemisphere at a low frequency. This results in down-regulation of the excitability of the healthy side and restoration of the balance between the lesioned and healthy sides, allowing the lesioned side to regain function. Adding navigation to TMS is the key to finding the exact location and orientation of the e-field of the motor area that should be inhibited by stimulation. The stimulation is then accurately repeated in every session, assuring the dose is applied to the correct place.
Founded in 2000, Nexstim is committed to improving the quality of life of patients with significant unmet clinical needs. The advanced technology providing navigation to TMS has led to Nexstim being the world leader in image-guided transcranial magnetic stimulation (TMS). Nexstim has pioneered the technology for brain diagnostics and with FDA-clearance of the Navigated Brain Stimulation (NBS) System for non-invasive pre-surgical mapping. NBS is recognized as the emerging standard for pre-operative direct functional mapping. Nexstim’s NBS System enables treatment of brain injury and disease using rTMS with accurate and repeatable 3D-guidance of therapeutic electrical field.
Nexstim’s non-invasive Navigated Brain Stimulation System is not approved by the Food and Drug Administration for therapy in commercial use in the United States and is available to select physician for investigational use only.