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  • "It helped me greatly. It’s just immeasurable the progress that I have made."

    Dwayne Nelson
    Stroke Trial Patient
  • "What we found is that there are areas of the brain usually where the lesion is that are less active than they used to be, and there are actually areas on the brain on the opposite hemisphere, the healthy area of the brain, that are more active than it used to be."

    Lynn Rogers
    PhD

Nexstim has recently conducted a multi-center trial in twelve different sites in the US for the purposes of showing the clinical efficiency of its therapeutic products by way of Phase III trials called Navigated Inhibitory rTMS in Contralesional Hemisphere Evaluation (NICHE) trial.

At the second interim analysis (of data from 138 patients, with safety data from 199 patients), the Data Safety and Monitoring Board (DSMB) recommended that the trial be stopped due to pre-specified criteria for futility being met and therefore the trial being unlikely to meet its primary endpoint. The NBT® active treatment in the NICHE trial gained highly clinically meaningful positive results, with over 2/3 of the patients responding. Surprisingly, the sham treatment also resulted in similar clinical responses, well above expected sham response levels, albeit from a different stimulation method to the active NBT® treatment. Both stimulation protocols were provided with Nexstim proprietary e-field based navigation technology.

The unexpected sham treatment data have led Nexstim to file a patent application on this novel stimulation method.The response in the sham group caused the interim analysis of the study to trigger the futility analysis criteria because of the lack of separation of the groups. The primary endpoint of the study was to demonstrate a difference between the active NBT® and sham groups of patients to achieve a clinically important functional improvement from baseline to six months post-treatment. No safety concerns were observed throughout the study.

Nexstim will submit the FDA 510(k) De Novo based on the clinical data and work towards finding a path forward for this significant therapeutic treatment to increase the benefits of this clinical patient work compared to current clinical rehabilitation. The NBT® is already CE-marked for stroke rehabilitation.

The Phase II trials were designed as a proof of protocol study to prove the efficacy of the NBT® System in improving hand and arm functionality in a single center with a smaller group of patients. The trial was performed in 2010 -2013 at the Rehabilitation Institute of Chicago (RIC) which has been ranked the number one rehabilitation hospital in the US for 23 consecutive years, and was led by Dr. Richard L Harvey who is one of the leading experts in the field. The study was performed to establish efficacy of a clinical protocol for use in a subsequent multi-center study (Phase III).

The randomized and controlled clinical Phase II study was conducted on 29 stroke patients with sub-acute stroke, of which 19 received NBT therapy (1Hz contralesional NBS-guided repetitive TMS) and 10 received sham treatment. The sham group went through the same experience, however did not receive magnetic stimulation treatment. All patients received occupational therapy in conjunction with rTMS treatment, allowing for the comparison of NBT to conventional therapy. Out of the group receiving NBT treatment, 84% showed clinically important improvement (over 4.5 points in the Fugl-Meyer Scale).

Improvements in upper extremity movement and control in the NBT group was substantial. The magnitude of improvement that an absolute increase of 13.2 on the Fugl-Meyer Scale would equate to the difference between being able to hold an object and being able to button a shirt. Nexstim believes that this level of improvement could be the difference between requiring constant care and being able to live independently.

Basis for TMS therapy

Transcranial magnetic stimulation (TMS) when given in a repetitive form (pulse trains), can be used to control activity of the brain by either exciting (up-regulating) or inhibiting (down-regulating) sides of the brain cortex. The motor cortices responsible for muscle control in the left and right hemispheres of the brain are strongly interconnected, with each side naturally inhibiting the activity of the other side, achieving a natural balance. In cases where one side is lesioned, as in stroke, the natural balance between the hemispheres is disrupted, as the healthy side attempts to compensate through stronger inhibition of the lesioned side. Resulting in the ability to participate in motor training, which is necessary for the recovery of motor control, is severely challenged.

Role of TMS

A recent discovery is to use repetitive transcranial magnetic stimulation (rTMS) to control the balance between healthy and lesioned sides of the brain. Two potential roles have been described for the technology in stroke recovery: utilizing 1Hz repetitive stimulation to inhibit the healthy side or utilizing 10Hz repetitive stimulation to activate the damaged side. Nexstim has decided to utilize inhibiting stimulation on the healthy hemisphere, as the alternative treatment using direct stimulation to the lesioned side of the brain is believed by the Company to be risky due to the potential disturbance of natural healing processes. By inhibiting the healthy hemisphere the Nexstim's NBT® System is facilitating and enhancing the natural healing process by lowering inhibition on the lesioned side. Research seems to suggest inhibiting the healthy side may be more effective, but further studies are required.

 

Nexstim’s noninvasive medical device holds both CE marking and FDA clearance for NBS System in motor mapping. Nexstim is the leader within the e-field based navigation devices and is the only one having clinical proof and FDA clearances for its NBS navigation devices.

Nexstim’s non-invasive Navigated Brain Stimulation (NBS) 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.

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