PEARL Study Initiated to Assess the Long-Term Effects of the EASEE® Brain Stimulator – 135 People with Epilepsy* Can Participate
Berlin, 13.09.2024 – Technological devices that deliver electrical pulses to nerve tissue—known as neurostimulation therapies—have already helped many people alleviate chronic pain. Many Parkinson's patients benefit from implants that can ease specific symptoms, such as tremors, with small electrical pulses. However, patients with epilepsy often did not experience significant relief with the therapeutic devices available so far. The recent approval of the innovative EASEE® pacemaker aims to improve the situation for people with epilepsy in the future. EASEE® is the world's first minimally invasive brain pacemaker to receive MDR-compliant CE certification for the treatment of focal epilepsies*.
It is inherent that entirely new therapeutic methods cannot provide long-term data at market approval. For EASEE®, there are currently experiences from 32 patients** with good results over two years (Schulze-Bonhage et al., 2023). To make the data and thus the evidence of the effectiveness of EASEE® more robust in a larger cohort over three years, the PEARL study was initiated (PEARL stands for Providing Early Assessment in Real Life).
Prof. Bettina Schmitz, Chief Physician at the Berlin Epilepsy Center at the Vivantes Humboldt-Klinikum Berlin, is the principal investigator for PEARL. She has extensive experience documenting the progression of large patient groups with epilepsy, as she has been leading the GRAPE study (German Registry of Antiepileptic Drugs and Pregnancy with Epilepsy) for many years. Together with the epilepsy-specialized centers in Erlangen, led by Professor Hajo Hamer, and Radeberg, led by Dr. Thomas Mayer, Professor Bettina Schmitz designed the study concept and fulfilled all the necessary regulatory conditions for its implementation.
Up to 135 adult patients** with focal epilepsies who have not been sufficiently helped by medication and for whom surgical removal of brain tissue is not an option will be included in the study.
Participation in the PEARL study is now available in Berlin, Erlangen, Radeberg, and Marburg. Additional centers will be opened shortly. Interested patients** and their treating physicians** are welcome to contact pearl@vivantes.de by email.
For patients** who are not yet of legal age, a parallel study called EASEE4YOU is being conducted, which can include patients** aged 12 to 17 years. The goal of the pediatric study with EASEE® is to obtain market approval for this age group as well.
About Precisis and EASEE
Precisis GmbH, based in Heidelberg, develops bioelectronic methods to direct therapeutic currents to specific target areas of the brain. Through AI-based learning models, certain nerve cells can be activated or inhibited. So far, the greatest success for Precisis has been shown by EASEE® in the treatment of epilepsy. EASEE® is used to suppress epileptic seizures. More information about the PEARL study, which is financially supported by Precisis, can be found at easee.precisis.de/en/health-care-professionals/studies/easee-pearl/.
Information about the pediatric study can be found at easee.precisis.de/en/health-care-professionals/studies/easee4you/
* Patients with focal epilepsies who have not been adequately helped by medication and for whom surgical removal of brain tissue is not an option.
** For better readability, we use the masculine form but, of course, this also applies to female individuals.