Ms. Prof. Dr. med. Daniela Berg, Director of the Department of Neurology at Kiel University Hospital, spoke of “a precision landing in the fight against Parkinson’s” in an interview with the Parkinson Foundation in connection with MRgFUS at the turn of the year 2021/2022. For several years there has been hope for drug-resistant Parkinson’s patients, especially when it comes to tremor.”
Clinical picture and course of the disease
A distinction is made between tremor patients in essential and from Tremors caused by Parkinson’s disease. In advanced stages, tremor patients are often no longer able to carry out everyday tasks, which quickly leads to reduced independence and quality of life and to progressively increasing care requirements, early retirement and, in around 25%, a great need for care.
Essential tremors and tremors caused by Parkinson’s have so far been treated primarily with medication, although the currently available medications can only alleviate tremors, not cure them.
Escalatory therapies (neurosurgical treatments or pump therapies)
As Parkinson’s disease or tremor disease progresses, it occurs after about three to eight years (varies from person to person). resistance to drug therapy one with so-called fluctuations in effect and dyskinesias, which can no longer be controlled by oral or transcutaneous medication alone. In this phase, so-called escalatory therapies are used.
In the guideline dated December 16, 2022, the European Academy of Neurology (EAN) together with the European Section of the Movement Disorder Society (MDS-ES) have identified the currently 3 most common invasive procedures according to GRADE standards (Grading of Recommendations, Assessment, Development and Evaluation). Recommended procedure:
- deep brain stimulation, in which electrodes drilled holes through the skull are brought to specific areas of the brain, connected to a generator located under the skin and then stimulated,
- L-dopa or apomorphine pumps, which enable the same levels and work evenly through infusion into the patient
- MRI-guided ultrasound treatment (MRgFUS)
The MRgFUS uses magnetic resonance technology to localize the source of the tremor in the brain. This target point is then brought to the source of the tremor with high focus (2/10 mm) using 1024 ultrasonic waves under magnetic resonance control. The focused ultrasound allows controlled, continuous energy control to over 60 degrees Celsius, which leads to a targeted thermal lesion. This interrupts the TREMOR NETWORK in the brain and renders it ineffective. With this procedure, the reduction in shaking associated with arm tremor can be noticed immediately during the procedure. The arm tremor is usually reduced to approx. 10% – 30% at the end of the procedure.
You may experience headache, dizziness, dizziness, nausea or stomach pain during or shortly after treatment.
In the EAN guidelines is summarized in the conclusion for practice: “The use of invasive treatments is now possible for various clinical constellations with good success. “In addition to drug therapy, they have become an indispensable part of modern Parkinson’s treatment.”
Sustainability of MRgFUSPersonal experiences
The head of the Karlsfeld-Dachau Parkinson’s self-help group, Karl Walter, and his deputy, Klaus Englert, who have both been living with right-sided arm tremor for 10 years, decided to have MRgFUS therapy carried out in November 2022 after a week of testing at Kiel University Hospital. Both patients received a recommendation to carry out an MRgFUS procedure in their respective findings.
Karl Walter and Klaus Englert report on a highly professional procedure, accompanied by great human closeness from the doctors and the experience of immediate impact during the procedure.
With Karl Walter Due to “moderate skull penetrability”, sufficient temperatures could only be achieved with difficult treatment (6 lesions). Postoperatively there was a good tremor response with only slight unsteadiness in gait, which was due to swelling.”
During the follow-up examination in July 2023, a significant reduction in tremor was confirmed.
A year after the operation, Walter only feels “slightly burdened by the tremor in off-phases when he is tense.” The daily levodopa intake could be maintained at the level before the MRgFUS procedure with a 90% elimination of the tremor burden.
At Klaus Englert wThe response to treatment was unexpectedly good with only 2 lesions. On the day of the procedure and the following day, the tremor was 100% eliminated. Side effects subsequently occurred. The result was severe unsteady gait, a right-hand spin and movement disorders. These subsided again over the next 8 weeks. However, the tremor also came back strongly in the off phases. After 3 months, an improvement in tremor symptoms of 20% was attested. The medication was changed and 6 months after treatment, the daily levodopa intake was reduced by almost half.
Official statistics from the manufacturing company confirm that 100 people (P) still undergo the procedure after one year
a feeling of numbness or tingling in the face, legs, hands or fingers in 15, persistent problems with walking (unsteady gait) in 10, changes in the sense of taste in 4, problems with coordination of movements in 4, problems with balance in 2
One 5-year follow-up study on MRgFUS therapy against essential tremor showed that the treated side remained significantly improved even after 5 years, and with regard to the quality of life of the treated patients, the improvement achieved with the procedure was maintained.
Do tremor patients have cause for hope in 2024? Current situation
With around 1 million tremor patients (parkinson-caused and essential). Deutschland two MRgFUS clinics (the University Clinics of Bonn and Kiel have been the Paracelsius Clinic in Kassel since March 24). So far, 200 tremor sufferers have been treated with MRgFUS in Germany. Currently, an average of 2 tremor sufferers are treated per week per clinic.
Switzerland with around 100,000 tremor patients, it has 3 MRgFUS clinics and 650 MRgFUS patients.
Spain with around 650,000 tremor patients, has 14 MRgFUS clinics and 1,300 MRgFUS therapy patients.
MRgFUS has been in testing worldwide since 2016; A total of more than 15,000 tremor patients were treated.
With 200 treated tremor patients in Germany as of the end of 2023, Germany has to be one attest to a clear undersupply of tremor patients.
The fact that around 25% of tremor patients, that is around 275,000 patients, are facing early retirement and the early need for full care is a particular hardship for these people and for their relatives.
There is an urgent need for humanitarian action!
The treatment results available worldwide to date suggest that a tremor patient treated with MRgFUS will become a serious need for care much later than the patient who was not treated or treated differently, if at all.
A stay in a nursing home costs around €6,000.00 per month in Germany.
If, for example, 1000 tremor patients could avoid a nursing home stay through MRgFUS therapy (costs approx. €16,000.00 per patient) in one year
€72,000.00 x 1,000 patients = €72,000,000.00 saved, not including the costs of early retirement.
The total number of currently potentially around 275,000 tremor-related care stays, calculated cumulatively, is estimated Recognize billion-dollar savings potential while simultaneously reducing unnecessary suffering!
Current determining factors/influencing factors
Until further study results are available, the DGN will primarily double that expensive deep brain stimulation (DBS) with opening of the skull and greater risks for the patient is recommended.
Cost undercoverage has resulted in the two clinics only treating a few patients until further notice.
Cost estimate of €16,000.00 to his health insurance (subsidy) and a reimbursement request
This was rejected with a note
“The above-mentioned treatment is not a treatment within the meaning of the Federal Aid Ordinance. This treatment is not recommended according to the guideline update “Invasive Parkinson’s therapy from July 12, 2022…”
When actually invoicing, Karl Walter was able to refer to the European guidelines of December 16, 2022, with which MRgFUS was declared “an indispensable part of modern Parkinson’s treatment”, which then prompted the aid to cover the costs without restriction.
The low number of patients treated weekly is due, among other things, to the fact that the MRgFUS departments have to share the MRI machine with other departments.
This restriction can be avoided by purchasing not only an FUS device (€2.5 million) but also an MRI device (€1.5 million) at the same time.
With optimal operational organization, around 500 tremor patients could be treated every year
Hope for tremor patients in Germany
Ms. Prof. Dr. Brit Mollenhauer, chief physician and medical director of the Paracelsus Elena Clinic, summarized the result with the words: “The MRgFUS system is an important component in the treatment of tremor and also for Parkinson’s patients.”
From the patient’s perspective, there are no longer any reasons in Germany not to use MRgFUS for the benefit of tremor patients.
This assessment was prepared by two tremor patients from the Karlsfeld-Dachau self-help group (Karl Walter and Klaus Englert), who successfully carried out MRgFUS therapy at the Kiel University Hospital (UKSH Kiel) in March and May 2023 due to a very severe hand tremor have lived an almost tremor-free life since then and hope that as many tremor patients as possible will soon be able to live a similar life.
Karlsfeld, 22.09.2024
The successfully treated members of the Karlsfeld-Dachau self-help group (Mr. Walter (walter-karlsfeld@t-online.de) and Mr. Englert (klausenglert@aol.com) are happy to answer questions.
