Nexstim Initiates Multicenter Clinical Trial on the Therapeutic Effects of Navigated TMS for Stroke Rehabilitation

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.

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

Texas

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.

About Nexstim:

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.

http://www.heraldonline.com/2014/06/11/6048156/nexstim-initiates-multicenter.html?sp=/100/773/385/#storylink=cpy

'Good Vibrations:' Brain Ultrasound Improves Mood

May 15, 2013 — Non-invasive brain stimulation techniques aimed at mental and neurological conditions include transcranial magnetic stimulation (TMS) for depression, and transcranial direct current (electrical) stimulation (tDCS), shown to improve memory. Transcranial ultrasound stimulation (TUS) has also shown promise.

Ultrasound consists of mechanical vibrations, like sound, but with frequencies far greater than the upper limit of human hearing, around 20 thousand to 20 million cycles per second (20 kilohertz to 20 megahertz). Ultrasound vibrations penetrate bodily tissue including bone, and are widely used to image anatomical structures via echo effects, e.g. visualizing unborn babies in mothers' wombs, and organs, blood vessels, nerves and other structures in medical procedures. Virtually every part of the body, including the brain, has been safely imaged with low to moderate intensity ultrasound.

High intensity, focused ultrasound can damage tissue by heating and cavitation, and has been used to ablate tumors and other lesions. 'Sub-thermal' ultrasound can safely stimulate neural tissue. In 2002 a UCLA group led by Alexander Bystritsky noticed beneficial side effects in psychiatric patients whose brains were imaged by TUS. A team led by Virginia Tech's W. Jamie Tyler has shown TUS-induced behavioral and electrophysiological changes in animals. A Harvard group led by S-S Yoo has used focused ultrasound aimed at mouse motor cortex to wag the mouse's tail. But clinical trials of TUS aimed at human mental states have been lacking.

Now, in an article in the journal Brain Stimulation, a group from the Departments of Anesthesiology and Radiology at the University of Arizona Medical Center in Tucson, Arizona has investigated TUS for modulating mental states in a pilot study in human volunteers suffering from chronic pain. A clinical ultrasound imaging device (General Electric LOGIQe) was used, with the ultrasound probe applied at the scalp overlying the brain's temporal and frontal cortex (visible on the imaging screen). In random order, each subject received two 15 second exposures: sham/placebo, and 8 megahertz ultrasound (undetectable to subjects). Following exposure, subjects reported (by visual analog scales) significant improvement in mood both 10 minutes and 40 minutes after TUS, but not after sham/placebo. In a followup study (led by University of Arizona psychologists Jay Sanguineti and John JB Allen) preliminary results suggest 2 megahertz TUS (which traverses skull more readily) may be more effective in mood enhancement than 8 megahertz TUS.

The mechanism by which TUS can affect mental states is unknown (as is the mechanism by which the brain produces mental states). Tyler proposed TUS acts by vibrational stretching of neuronal membranes and/or extracellular matrix, but two recent papers from the group of Anirban Bandyopadhyay at National Institute of Material Sciences (NIMS) in Tsukuba, Japan (Sahu et al. [2013] Appl. Phys. Letts. 102, 123701; Sahu et al [2013] Biosensors and Bioelectronics 47:141) have suggested another possibility. The NIMS group used nanotechnology to study conductive properties of individual microtubules, protein polymers of tubulin (the brain's most prevalent protein). Major components of the neuronal cytoskeleton, microtubules grow and extend neurons, form and regulate synapses, are disrupted in Alzheimer's disease, and theoretically linked to information processing, memory encoding and mental states. Bandyopadhyay's NIMS group found that microtubules have remarkable electronic conductive properties when excited at certain specific resonant frequencies, e.g. in the low megahertz, precisely the range of TUS.

Dr. Stuart Hameroff, lead author on the new TUS study, said: "This suggests TUS may stimulate natural megahertz resonances in brain microtubules, enhancing not only mood and conscious mental states, but perhaps also microtubule functions in synaptic plasticity, nerve growth and repair. We plan further studies of TUS on traumatic brain injury, Alzheimer's disease and post-traumatic stress disorders. 'Tuning the tubules' may help a variety of mental states and cognitive disorders."

http://www.sciencedaily.com/releases/2013/05/130515094825.htm