FAQs
Frequently Asked Questions
Am I suitable for treatment with tVNS®?
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tVNS® is a non-invasive device used in the treatment of sympathetic vagal imbalances. It can be used in patients of all ages from 3 years of age. It can be used at any age from newborns with the approval of the doctor.
In general, whether you are suitable for treatment is a decision that you will make in consultation with your doctor. If your doctor does not recommend or does not know the treatment, you can contact us. We can contact your doctor .
What does it mean for the tvNS® device to be medically approved?
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The manufacturer of the tVNS® therapy device, Germany-based tVNS Tehnologies GmbH, was established in Germany in 2003 and, as the world's pioneer of this technology, manages the worldwide clinical research and operations of the devices that have received the first medical approval in the world since 2010. With the medical approvals received in 2021 and 2023, it is the only auricular stimulation device that can safely apply vagus nerve treatment and is produced with the latest engineering technologies with the R&D and production team in Erlangen, Germany.
Stimulation of the vagus nerve with devices that do not have safety and medical approval can lead to very serious consequences ranging from respiratory to cardiac arrest.
Do I need to consult my doctor or device manufacturer for device settings when starting to use tVNS®?
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No. tVNS® is very easy to use. It can be easily adjusted without the support of a doctor with the device training and instructions for use. When you receive the device, approximately 2 hours of device usage training is given. Afterwards, all settings related to the device are made by Turkey with a remote Bluetooth-supported application. Your therapy protocol is shared with your doctor on a regular basis.
How often do I need to use tVNS®?
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Therapy with tVNS® requires a total of 2 to 4 hours of sessions per day, depending on the indication used. The duration of these sessions can be planned as 1.5 hours. The time at which it will be is determined according to both the indication used and the daily routines and needs of the patient.
What side effects might I experience?
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Therapy with tVNS® is a treatment with very few side effects. In general, two types of side effects are observed. The first of these is local side effects that may occur in the form of itching, redness and pressure sores in the area where the outer auricle is stimulated. On the other hand, since the stimulation of the vagus nerve can affect the autonomic nervous system, systemic side effects may occur. These may include headache, nausea, or dizziness. As with other drug or neurostimulation treatments, an increase in seizures may occur.
However, it differs from other treatments in that the side effects usually disappear soon after the end of treatment.
Can I avoid taking medication if I choose tvNS ® treatment?
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tVNS® therapy is an adjunct to medication, if you decide to stop or reduce your medication you should discuss this with your doctor. In general, it is not recommended to start a new drug, increase or decrease the dose, or start it simultaneously with another treatment at the time of initiation of treatment. In this way, we can observe the effects of tVNS® more objectively.
How long will I need to use tVNS® treatment and how long will it take for the treatment to work?
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tVNS® treatment is not an acute treatment, there is no external drug intake. It provides a long-term treatment option by stimulating certain centers of the brain and increasing the release of neurotransmitters over time, eliminating the sympathovagal imbalance. Like most drugs and neuromodulatory therapies for epilepsy treatment, tVNS® therapy is a long-term therapy. Even if you do respond to treatment with tVNS®, the effect usually starts with a delay of just a few weeks to months.
Can tVNS ® be used by children?
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tVNS® can be safely used by children under parental supervision. It was applied to two different 8 and 9 months old babies with the approval of a doctor in Turkey and no negative results were encountered. If it will be used with children, the sessions must be given under parental supervision. tVNS® can be used by children 6 years and older. If it is to be used in children younger than 6 years old, the sessions must be performed under the supervision of the parents.
How can I access tvNS ® ?
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If deemed appropriate by your doctor for the treatment of tVNS®, you can apply to our center and obtain the device. After planning how to use the device and the treatment protocol, you can start the treatment by receiving remote treatment support.
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What are the approved indications of the device?
Indicated since 2021 for Anxiety, Migraine, Autism, Cognitive Impairment, Depression, Fibromyalgia, Epilepsy, Inflammation, Prader-Willi Syndrome, Sleep Disorders, Stroke, Tinnitus, Asthma, Crohn's Disease, Atrial Fibrillation and Parkinson's. Apart from this, researches continue on different subjects such as neural plasticity, coma and diabetes.
What is the usage rate of tVNS® in the world?
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tVNS® is the only medically approved sympatovagal ear stimulation treatment in the world, and is used in more than 40 countries in the world's most specialized universities, hospitals and clinics.
We mobilize all this communication network to create treatment protocols for patients with special conditions, and we become the architects of medical studies that determine the future of neuromodulation treatments.
What are the indications (effects) of the t-VNS ® device?
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1) It undertakes the task of increasing the activity of the parasympathetic nervous system (resting mode).
2) It provides the balance of neurotransmitter hormone that the body cannot produce enough.
3) It helps to increase brain plasticity (Neural plasticity /: the ability of the brain to undergo structural or physiological changes) in the medium and long term.
4) Reducing inflammation. In recent years, clinical studies of tVNS® have proven the inflammatory effects of nerve stimulation.
Inflammation (colloquially known as inflammation/inflammation) in the simplest terms, against all kinds of foreign factors or internal-external tissue damage of living tissue; cellular (cellular), body fluid (humoral) or veins (vascular) are some series of reactions on the basis. By developing inflammation, the body actually aims to destroy the disease factor, to isolate the factors that it cannot destroy from healthy tissues or to eliminate damaged tissues. It is divided into acute and chronic inflammation.
Examples of acute inflammation: Redness, swelling, fever, pain, edema, increased temperature Examples of chronic inflammation: Cancer, ALS, heart diseases, diabetes, hypertension, asthma, depression, neurological diseases
Is the response time of vagal stimulation therapy (vagus nerve stimulation) the same in patients of all ages?
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It has been observed that the earlier the patient starts vagal nerve stimulation therapy or the shorter the epilepsy history, the shorter the response time to the disease. For example, a 40-year-old epilepsy patient may take longer to respond to vagal nerve stimulation treatment than a pediatric epilepsy patient.
Is nonsurgical tVNS (through the skin) vagus nerve stimulation) only a preliminary step for patients responding to surgical VNS therapy? Should epilepsy patients who respond to cutaneous vagus stimulation therapy switch to invasive therapy?
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tVNS® therapy may be a preliminary step for invasive vagal nerve stimulation requiring surgical intervention, but it is also an alternative treatment modality. The reasons for this are;
I. Not every patient is suitable for invasive intervention.
II. In case of failure to respond to treatment, removal of the electrode is difficult and risky, as the tissues of the vagus nerve wrap and fuse with the electrode. Even if the battery is removed, the patient will have to live with an inactive implant electrode in his body for life. It may cause pain or pressure, and infection may develop over time.
Can the transcutaneous (through the skin conduction/non-invasive) method and the Invasive (surgical implant) method give the same effect in vagal nerve stimulation?
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According to fMRI studies, it has been proven that both methods stimulate the same points in the brain. However, tVNS® has some advantages over the invasive method:
1. Contrary to the invasive alternative, since it has a rechargeable battery, it can give electrical stimulation as more frequent and intense programs.
2. As with the invasive alternative, high currents up to 5MA can be given, as it does not directly give the electric current attached to the nerve and does not pose the risk of nerve damage.
Why does not every patient respond to his treatment in the same way or at the same rate?
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There are different hypotheses about this, one of them is myelin thickness. Thick myelin nerves conduct electrical conduction better, and in this way vagus nerve stimulation can be done more effectively. Myelin thickness can vary from person to person genetically. Studies have shown that patients with thick myelin nerves respond better to treatment.
What is the direct current (milliamps) to stimulate the ear?
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There are scientifically proven studies on this subject. The minimum electrical current required to stimulate the vagus nerve is kept somewhat below the pain/pain threshold so that it does not activate the pain nerves. For this reason, there should be no pain or pain during stimulation, but a distinct vibration sensation. This is the most optimal stimulation intensity and should be at a level that does not disturb the patient.
In which situations can the device not be used during the day?
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You can safely use the tVNS® device while mobile, while walking, watching TV, reading a book, or at the computer. For safety reasons, it is recommended not to be used while driving to avoid distractions. It is recommended that the device be turned off when passing near high magnetic fields and devices that create high magnetic fields. Apart from this, it can be used in children both while they are asleep and awake. Adults are advised not to sleep while performing self-therapy. In order to avoid the risk of any cable entanglement around the neck, our children can be given therapy both while awake and asleep under parental supervision.
To what extent does tVNS ® treatment affect epileptic seizures?
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According to clinical studies conducted in 2000 patients using the tVNS® device between 2010 and 2018, a significant reduction in the severity and number of seizures was observed in an average of 60% of the patients. It can be said that a secondary effect, which is widely seen, is an increase in vitality, cognitive progress and improvement in sleep patterns. It can completely stop seizures in 10-20% of patients.