Trigeminal Nerve Stimulation (TNS)

Trigeminal Nerve Stimulation (TNS) is a novel medical treatment in which mild electrical signals stimulate branches of the trigeminal nerve (the largest cranial nerve) in order to modulate the activity of targeted brain regions. NeuroSigma is developing two embodiments of TNS: eTNSTM (TNS with external electrodes and an external pulse generator) and sTNSTM (subcutaneous electrodes and implantable pulse generator).

The trigeminal nerve conveys information to important structures in the brain, including the nucleus solitarius, the locus coeruleus, the vagus nerve and the cerebral cortex. These areas are known to play key roles in seizure inhibition and initiation. The trigeminal nerve also specifically sends signals to the anterior cingulate cortex, which is involved in mood, attention and decision-making.

Clinical trials are currently in progress for epilepsy, depression and post-traumatic stress disorder (PTSD). A clinical trial in attention-deficit hyperactivity disorder (ADHD) will soon be starting.

Positron Emission Tomography (PET) imaging studies in humans have identified a potential mechanism of action for the treatment of epilepsy, depression and other brain disorders. eTNSTM activates or inhibits key regions implicated in these disorders and changes in blood flow were observed with minutes of therapy.

Epilepsy affects over three million Americans. Over one million of these people have drug-resistant epilepsy (DRE), which frequently leads to unemployment, injuries and carries a significantly increased risk of death.

There is growing interest in neuromodulation therapies for epilepsy. Trigeminal nerve stimulation is an emerging and promising therapy with unique advantages relative to other current therapies: it can be delivered externally, bilaterally, at competitive costs and with potentially lower risks.

Stimulation of the trigeminal nerve and its related structures have been shown to inhibit seizures in animal models. Human trials have been conducted at UCLA for nearly ten years. A randomized, active-controlled, double-blind, dual-center study at UCLA and USC was completed in April, 2011. Phase III clinical trials are currently in the planning stages.

Eighteen million adults in the United States suffer from depression and at least half of these people do not seek the necessary treatment.

Major depression is a severe form of depression. People with major depression usually experience a sad or depression mood and/or a loss of interest or pleasure in life's joyful activities. Often the experience also includes physical symptoms, such as sleep disturbances, low energy, changes in appetite, and fatigue. These symptoms, plus difficulties with concentration, memory, and decision-making, can cause depression to interfere with a person's normal functioning in life, whether in the workplace, in school, or with family and friends.

A person may experience only one episode of major depression, but often there are repeated episodes over an individual's lifetime. About one in six people will experience at least one major depressive episode during their life. Depression affects people of all races, incomes, ages, and ethnic and religious backgrounds.

Trigeminal nerve stimulation for depression has been studied at UCLA for several years, with positive research findings published in 2011. A Phase II, double-blind clinical trial is in progress with expected completion in late 2011.

Post-Traumatic Stress Disorder (PTSD)
Post-traumatic stress disorder is an anxiety disorder that can develop after exposure to a traumatic or terrifying event in which serious physical harm occurred or was threatened.

Patients with this illness commonly report difficulty sleeping, persistent frightening recollections of the traumatic event, sudden outbursts of anger or anxiety, feeling detached or numb, avoidance of people or places that are reminders of the experience, as well as many other debilitating reactions. PTSD is a highly prevalent lifetime disorder that can often persist for years.

The Veterans Administration (VA) reports that 400,000 veterans are currently receiving compensation for PTSD and they expect the number to grow higher as long as the U.S. still has troops deployed in combat around the world.

A Phase I, open-label clinical trial of trigeminal nerve stimulation for PTSD is currently recruiting at UCLA.

CAUTION: Trigeminal Nerve Stimulation (TNS) is an investigational therapy and limited by United States law for investigational use.