Nexstim, a medical device company, has launched a multicenter clinical trial to determine the therapeutic effects of navigated repetitive transcranial magnetic stimulation (rTMS) for stroke rehabilitation. The 2-year study, called the NICHE trial (Navigated Inhibitory rTMS in Contralesional Hemisphere Evaluation), will be conducted at 12 rehabilitation sites in the United States. The clinical trial will be a double-blind, randomized, and sham-controlled trial, according to a Nexstim news release.
The Nexstim news release notes that researchers will enroll up to 200 patients and will look to replicate the initial findings of a single-center trial conducted by Richard Harvey, MD, of the Rehabilitation Institute of Chicago. The study approached stroke rehabilitation through a new combination of therapies, which produced notably greater gains in patients’ motor function 6 months post stroke. The combination of rTMS with occupational therapy opened the door to improving the quality of life for stroke survivors, as noted on the Nexstim news release.
The study showed more than 80% of the active group received a clinically meaningful response rate.
The rTMS is used to simulate the patient’s non-injured brain hemisphere at a low frequency, which results 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, as indicated on the Nexstim news release. The use of navigation in TMS helps find 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.
The research team for this multicenter trial includes researchers from: Arizona (Mayo Clinic); California (Ranchos Los Amigos National Rehabilitation Institute); Georgia (Shepherd Center); Illinois (Rehabilitation Institute of Chicago); Indiana (Indiana University); Massachusetts (Spaulding Rehabilitation Hospital); New York (Columbia University, Burke Rehabilitation Center); North Carolina (Duke University); Ohio (Ohio State University, University of Cincinnati); and Texas (TIRR Memorial Hermann Hospital).