The double-blinded, randomized, and sham-controlled trial, conducted by Nexstim, is expected to determine the therapeutic effects of navigated rTMS (repetitive transcranial magnetic stimulation) in the rehabilitation of stroke patients. This innovative therapy combines occupational therapy with navigated transcranial magnetic stimulation (nTMS). Twelve top rehabilitation sites across the country will be conducting this two-year trial, called the NICHE trial (Navigated Inhibitory rTMS in Contralesional Hemisphere Evaluation).
“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. We are dedicated to take this further and bring this to the market for the patient care,” said Janne Huhtala, CEO of Nexstim.
Dr. Gerard Francisco, chief medical officer at TIRR Memorial Hermann and chair of the department of Physical Medicine and Rehabilitation at The University of Texas Health Science Center at Houston (UTHealth) Medical School is the principal investigator. Along with co-investigator Nuray Yozbatiran, PhD, P.T., he has stated that the Nexstim study will tell researchers if non-invasive brain stimulation is able to magnify the benefits of occupational therapy for people suffering arm and hand weakness as a result of stroke.
“This will be a great demonstration of how ‘traditional’ therapies and modern technology can work in synergy to facilitate recovery from stroke,” said Dr. Francisco. “This technology is a way to directly affect changes in the brain damaged by a stroke, rather than merely teaching a person to compensate for lost function.”
Dr. Richard Harvey, Medical Director of the Center for Stroke Rehabilitation in the Rehabilitation Institute of Chicago (RIC), developed the protocol with Nexstim and conducted the single center trial. Along with his team at RIC, Dr. Harvey presented the trial results at the International Stroke Conference of the American Heart Association in February, under the title ‘The Contrastim Stroke Study: Improving Hand and Arm Function After S’.
“This particular study is in line with the mission of the NeuroRecovery Research Center, to use contemporary technology to boost the benefits of established physical and occupational therapy for persons with neurologic problems such as spinal cord injuries, brain injury, stroke, and muscular sclerosis,” Dr. Francisco states.