On the Tremipen® is only one round black button in the middle of the device. This is the ON button. To switch on the Tremipen®, push the ON button briefly; pushing for a longer time is not necessary. After the measurement is performed, the results are immediately shown on the display. With another push to the ON button it is possible to toggle between the two results (stated in mG and Hz). The result in mG shows the tremor amplitude (force of shaking), the result in Hz shows the frequency of the tremor. The Tremipen® switches off automatically after about 10 seconds.
The measurement process with the Tremipen® is very easy and quickly performed: including the preparation time, the measurement process takes about 40 seconds. The Tremipen® is switched on via a push to the ON button. The Tremipen® provides 5 seconds of preparation time, then the measurement process starts. The measurement process itself takes only 30 seconds. The results are immediately shown on the display after a measurement.
The handling of the Tremipen® is easy and nearly identical to the handling of a clinical thermometer. A measurement can be performed without any medical expert knowledge. To switch on the Tremipen® push the ON button briefly. As soon as the Tremipen® is switched on, the device provides 5 seconds of preparation time to bring yourself into the right position. The positions, that can be chosen for a measurement, are depending on the tremor type but in every case the fingers need to rest onto the grip recess.
After the 5 seconds of preparation time a beep tone sounds and the measurement process begins. Hold the device for the next 30 seconds with a loose grip in your hand and avoid active movements. The 30 seconds of measuring time are accompanied by moving arrows on the display, in the end another beep tone sounds.
The results are immediately shown on the display. The first result that is shown on the display is the result for the tremor amplitude (stated in mG), the second is the one for the tremor frequency (stated in Hz). With pushing the ON button, it is possible to toggle between the two results.
The results can be written down for objective therapy monitoring that attending doctors see how their patients’ tremors behave between two appointments. After a measurement the Tremipen® switches off automatically.
The Tremipen® operates with a common AAA battery. Tremitas recommends using the brand VARTA Industrial, because all functionalities of the Tremipen® were tested solely with this battery type. When a battery needs to be replaced because its energy level decreases or is too low, a battery symbol is shown on the display of the Tremipen®. To change the battery, open the battery case, insert a new battery and slide back on the cover. It is important that you pay attention to the polarity; if the battery is inserted wrongly the Tremipen® cannot operate. Take care about the proper recycling of the used batteries.
If the Tremipen® is used regularly, for two measurements per day, the battery works about 6 months. This only applies to the by Tremitas recommended VARTA Industrial battery. If the Tremipen® is used more often, e.g. in clinics or doctor’s offices, the lifespan of the battery may decrease.
It is important that the inserted battery stays in the Tremipen® until it is empty. The Tremipen® has an internal temporary power supply that is used by the device when no battery is inserted. The internal power supply guarantees that the measurement results, that are stored within the Tremipen®, won’t get lost. As soon as the new battery is inserted, the Tremipen® will use the battery again instead of its internal power supply.
It is possible that the Tremipen® cannot be switched on after a battery change. In that case the Tremipen® still uses the energy of the internal power supply. Because the internal power supply’s purpose is to keep the stored measurement results save and not to power the measurement electronics, a measurement cannot be performed in this state and the Tremipen® cannot be switched on. When the Tremipen® uses its fully charged internal power supply, voltage is created. As long this voltage is upright, the Tremipen® won’t use the battery. To bring the Tremipen® to using the battery, the voltage of the internal power supply needs to be reduced. To reduce the voltage, means to bring it down from 100%, the inserted new battery needs to be removed again. Because the internal power supply is the only energy source for the Tremipen® without a battery, it is used by the device and its voltage decreases. After waiting for some minutes, the battery can be put back in and the Tremipen® can be used normally again.
Except from changing the battery from time to time there are no maintenance costs for the Tremipen®. Though as a medical device the Tremipen®’s functionality needs to be revaluated every two years. This is obligatory for medical devices to detect possible inaccuracies due to aging of components or similar. The maintenance service is not included in the purchase price of the Tremipen® and is charged separately.
Users should clean and disinfect their Tremipen® regularly, to prevent the breeding of bacteria or other microorganisms. If more than one user uses the same Tremipen®, it is important that the disinfection is done before every new user. For the cleaning of the Tremipen®, Tremitas recommends a nonaggressive tenside based cleaning agent (e.g. soap or detergents) or medicinal alcohol (e.g. Isopropanol with max. 70%). It is important that the the Tremipen® is not dipped into the cleaning agents, only wipe it with a dampened cloth. Wipe the Tremipen® dry immediately after the cleaning that no liquid can pour into the device.
Including the battery, the Tremipen® weights about 30 grams. The low weight of the Tremipen® guarantees precise measurements: the tremor is not influenced by unnecessary weight and can be captured straight by the sensors in the device. If a too heavy device would be used for tremor measurements, the actual tremor could be overlapped by a physiological tremor and the results would be falsified. The physiological tremor happens when muscles are overstrained: when someone holds a very heavy object with an extended arm, mostly a so-called postural tremor will occur – the muscles start shaking because the weight is too heavy.
The lifespan of the Tremipen® is 8 years from date of purchase. The lifespan is not bound to warranty, the warranty is two years from date of purchase. The Tremipen® uses precise electronic components and sensors. The sensors capture the shaking; the force and frequency of the tremor are evaluated by the electronics. The Tremipen® is a stand-alone device, that means it does not need any other devices for performing and evaluating a measurement. Due to that, its light weight and its handy form it can also be used mobile for measurements.
The Tremipen® was developed to measure the human tremor in the hands. Tremor can have many causes and is often a symptom of an underlaying disease. The two most known diseases, where tremor occurs as a symptom, are the Parkinson’s Disease and the less common but much more spread Essential Tremor. But not only with these two diseases the Tremipen® can be used; in general, the Tremipen® is capable to capture and monitor all different types of tremor. The Tremipen® is especially suitable for therapy monitoring of tremor diseases. Regular measurements create a course of the tremor and show objectively how a therapy (drug therapy as well as alternative approaches) affects the tremor. Read more about different therapies for tremor here
The most common method for tremor assessment is a look by a trained neurologist on the shaking hands. The doctor looks at their patients’ hands during the appointment and assesses the force of the shaking. Also, EMG (electromyography) and EMG-Accelerometers are used; but these huge and bulky stationary devices are only available in clinics or specialised doctor’s offices. They take a huge amount of time for the measurement process and the interpretation of the measurements, therefor they are not used very often. For a measurement with the EMG-Accelerometer, patients get wired. The measurement process and the interpretation of the results need to be performed by trained personnel. Such a procedure can take up to two hours.
The Tremipen® captures the shaking of the hands. Seen as physical process, shaking is a sequence of accelerations in the two- and three-dimensional dimension. The Tremipen® captures these accelerations and evaluates, how strong and how fast the shaking has manifested. That means the Tremipen® measures the force of the shaking (tremor amplitude) and the frequeny of shaking (tremor frequency). These two parameters are important for tremor quantification. The tremor frequency can give hints about the underlaying tremor disease because different tremor diseases develop different tremor frequencies. In general, patients with a Parkinsonian Tremor are shaking more slowly than patients with Essential Tremor. Get more information about different tremor frequencies here
You get significant data with the first measurement with the Tremipen®: it evaluates the tremor amplitude and the tremor frequency and shows the results immediately after the measurement on the display. To monitor a therapy and to create a course of the tremor, the shaking needs to be measured on a regular basis. If measurements need to be compared, they should always be performed at the same time of the day. How often a measurement is performed is an individual choice; the attending doctor can advise.
Measurements for monitoring a drug therapy are performed ideally twice per day, one measurement before the intake of a medication and one after the intake, when the medication starts to affect the tremor; that time depends on the type of medication. It is also possible to perform one measurement per day for therapy monitoring; these measurements should all be performed at the same time every day. Another variation is three measurements per month performed on three days in a row. Not only drug therapies can be monitored with the Tremipen®, it is also possible to monitor the effects of alternative therapies.
During a subjective assessment of tremor, a human assesses the shaking, without any measurement devices. Tremor patients monitor themselves in the time between two appointments and tell their doctors at the next appointment how the tremor behaved. Another assessment method is that a trained doctor looks at the shaking hands and assesses the force of the tremor. Mostly the force of the tremor is rated with scales. The two scales, that are commonly used to describe the tremor force, are the TETRAS (The Essential Tremor Rating Assessment Scale) and the UPDRS (Unified Parkinson’s Disease Rating Scale). Within these scales the tremor force is rated with numbers (0-4; e.g. 0 means no tremor, 4 means manifested strongly). You can read more information about these tremor assessment scales and how the results of the Tremipen® can be compared to them here
During an objective tremor assessment, the tremor is captured with measurement devices. Force and frequency are evaluated by sensors and can be determined exactly. Such an objective measurement device is the Tremipen® – it is as easy to use as a clinical thermometer and needs only 30 seconds to perform a measurement.
Yes, the Tremipen® is able to measure a tremor that seems invisible to the human eye. In general, the human eye is capable to detect fast movements in its sight. Tremor is a sequence of movements and changes. When the force of the tremor becomes too light, the human eye can not capture this movements anymore.
At first sight this should be no problem: if the tremor is too weak for the human eye to capture, it cannot be that bad. This is true if someone already has received a diagnosis and the tremor is weak because proper medication was chosen. If no disease was diagnosed, an invisible tremor can be an early sign of a disease. A Parkinsonian tremor is weaker in the beginning and starts increasing over time. But sometimes the typical tremor frequencies have manifested also while the tremor is still weak.
The tremor frequency, which is an indicator for a diagnostical process, can be measured with the Tremipen® also during the time while human eyes do not see any shaking. The Tremipen® uses sensitive sensorics that are capable of capturing a tremor that is invisible to the human eyes. This sensor technology was developed over years to capture the tiniest movements and changes of these movements. While the human eyes need to watch many other things too, the sensor was developed to capture tremor exactly.
International organisations like the “International Parkinson and Movement Disorder Society” (MDS) determine that the regular and objective evaluation of symptoms of diseases like Parkinson’s Disease are not only possible but necessary (tremor is one of these symptoms). For adapting therapies that calm the tremor individually it is important to create a course of the disease. Due to regular tremor measurements with the Tremipen® such an objective course of the disease can be created; it shows how the tremor behaves and develops. Also, the objective results show how a therapy is affecting the tremor. Both, therapies with medication or alternative approaches can be monitored with the Tremipen®. The parameters of the tremor amplitude and the tremor frequency can support doctors in their diagnostic process because different tremor diseases develop different parameters. In the year 1998, a table with the common tremor frequencies of different tremor diseases was published. You can find this table here
We want to provide two references for the results of the Tremipen® that are based on scientific data: The average tremor amplitude of a healthy human is approximately 3mG. 1 G equals the earth gravity. Seen as a physical process, tremor is a sequence of accelerations and therefore, because the Tremipen® measures these accelerations, mG is the unit the Tremipen® uses. The more forceful the tremor is, the higher the mG result is and vice versa.
We have additionally created two tables where we compare the Tremipen®’s results to international standards for a better understanding of the mG unit. The tables were generated from our own clinical trial and compare the Tremipen®’s mG unit to the ratings of the TETRAS and the UPDRS scales that are commonly used for assessing tremor. You can find these tables under measurement parameters, additionally it is possible to download them from our website. The tremor frequency, that the Tremipen® captures, is stated in Hz. The frequency shows how fast a tremor manifested and can give hints about the possible underlaying pathological process. Different tremor diseases develop different tremor frequencies. The frequency table is also available under measurement parameters or you can download it here
The time for tremor measurements with the Tremipen® can be chosen individually, it can also be discussed with the attending doctor. Possible times of day are in the morning after getting up, in the evening before going to bed, before the intake of a medication or some time after the medication has an effect. The time it takes a medication to show its effects on the tremor is depending on the type of medication. If you do not know when your medication starts to have its effect, please ask your attending doctor.
If the Tremipen® is used for therapy monitoring, it is important that the measurements are performed at the same time every day to better document the course of the tremor. If the measurements are performed at the same time, they can be compared to each other more easily.
It depends on the disease and the tremor type which position is the right one for a measurement with the Tremipen® but there are some standardised measurement positions On any account a position should be chosen were the tremor is present. To better compare the results, all measurements should be performed in the same position.
For the Parkinson’s Disease the rest tremor position is common, because a Parkinsonian Tremor mostly occurs as a rest tremor, when hands are lying still. To measure the rest tremor, the hands lay on the lap or on the armrests of a chair. The Tremipen® is held with a loose grip.
For the Essential Tremor, the postural tremor position is common, because the shaking often occurs while moving the hands. For measurements of postural tremor, the hands are extended forward in a 90° angle, the fingers of the hand that does not hold the Tremipen® are spread out. Which measurement position is the right one can also be discussed with the attending doctor.
In general, the Tremipen® is held like a regular pen. Thumb and index finger rest on the grip recess, the middle finger supports the Tremipen® from below. The Tremipen®‘s end with the battery case has to rest on the back of the hand. Due to that it is possible to hold the Tremipen® with a loose grip. The loose grip is important; with that no physiological tremor can overlap the actual tremor. The hand that is more affected by tremor should be chosen for the measurements. It is possible to measure the shaking in both hands with two sperate measurements. Which side should be chosen for measurements can also be discussed with the attending doctor.
The Tremipen® is a medical device and because of that the efficacy and the safety had to be proven in a clinical trial and with scientific literature. To test the Tremipen®’s technology, a clinical trial was performed at the Medical University of Graz/Austria in the year 2016.
This clinical trial was not a random trial, it was a strictly regulated medical device trial. At such trials the local ethic commission as well as the the Austrian federal office for safety in health care had to approve the trial.
For several month, patients with tremor diseases (Parkinson’s Disease and Essential Tremor) were invited to participate in the trial. The shaking of the participants was assessed by trained neurologists as well as measured with the Tremitas system. This system is today also used in the Tremipen®.
The assessments of the neurologists and the measurements with the Tremitas system took always place at the same time, that the two assessments could be compared immediately. Sometimes the participants had to extend their hand forward, sometimes it was necessary that they laid their hands down in their lap. In some cases, they were also asked to write down simple sentences or draw lines. There were two scientific questions that had been answered positively in the trial:
The first question was if it is possible to objectively capture tremor with the Tremitas technology. In specialist circles it is asked in the question if a correlation with the gold standard exists. In this case, the assessments of the doctors about the shaking were the reference to which the tremor data was compared. This means the doctors were the gold standard. The doctors’ assessments were compared to the Tremitas technology’s results. The results were significant, that means the measurement results of the Tremipen® corresponded to the assessments of the doctors.
The second question was if it is possible to show the effects of a medication with the Tremitas technology. Therefor measurements were performed before the intake of the medication and after the medication had an effect. For that question, significance was also proved.
You can read the summary of the clinical trial here