Trial document
DRKS00020967
Trial Description
Title
Stimulation Induced ceREbellar syndrome after VIM/DRT-DBS – the SIREN-Study
Trial Acronym
SIREN
URL of the Trial
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Brief Summary in Lay Language
The study will include patients with essential tremor who are treated with deep brain stimulation and who are managed by the Department of Stereotactic and Functional Neurosurgery at the University Hospital of Freiburg. The aim of the study is to investigate a simple clinical marker - change in tremor frequency after switching off stimulation - to determine whether it is suitable for the diagnosis of stimulation-induced cerebellar syndrome, a side effect of deep brain stimulation.
Patients receiving deep brain stimulation (DBS) to treat their essential tremor often (13-40%) develop slowly increasing stimulation-induced cerebellar syndrome (SICS), which leads to recurrence of tremor and/or increasing coordination problems when walking. These complaints limit the patients' quality of life. The diagnosis is difficult to make in the typical outpatient care situation, as the symptoms develop gradually over a longer period of time and overlap with symptoms that occur with increasing essential tremor, but also with disorders in the delivery of sensory input to the cerebellum. However, it is important to identify the SICS, as the treatment is exactly the opposite of increasing essential tremor: with increasing essential tremor, stimulation can be increased, with SICS, stimulation should be reduced, as an increase only relieves in the very short term, while in the medium to long term, the SICS deteriorates. In patients with SICS who we have examined in detail on an inpatient basis and in whom we have switched the stimulation, it was found that the drop in tremor frequency when the stimulation is switched off could be a diagnostically useful parameter for identifying patients with SICS. Therefore, we would now like to examine all patients with DBS in essential tremor (those with and without SICS) who are treated at the outpatient clinic for this phenomenon of the drop in frequency when the stimulation is switched off and analyse how well this phenomenon is suited to identify patients with cerebellar symptoms. In addition, existing clinical data will be used to obtain information on the causes and effects of SICS.
Brief Summary in Scientific Language
The primary objective of the study is to investigate determining and prognostic factors for the presence of a cerebellar syndrome.
As the primary prognostic factor, we want to investigate whether the change in tremor frequency after switching off stimulation is suitable for diagnosing stimulation-induced cerebellar syndrome.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
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Organizational Data
- DRKS00020967
- 2020/02/28
- [---]*
- yes
- Approved
- 623/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- [---]*
Health Condition or Problem studied
- G25.0 - Essential tremor
- G46.4 - Cerebellar stroke syndrome
Interventions/Observational Groups
-
The following examinations with stimulation switched on and off are performed as part of a regular outpatient visit in patients with essential tremor treated with DBS:
- objective tremor test (frequency, power)
- scale-based tremor testing (Flag-Tolosa-Marin-Tremor-Rating-Scale) (video-assisted)
- scale-based testing of coordination/balance:
Scale for the Assessment and Rating of Ataxia (SARA) (video-based)
Tinetti Balance Assessment Tool
- Studies of movement and postural control (video-assisted):
Timed-Up-And-Go Test
Hand Coordination Test
Postural control
- Investigation of further clinical parameters
Pallesthesia
Nystagmus
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Diagnostic
- Single (group)
- [---]*
- N/A
Primary Outcome
The primary factor to be investigated is the difference in tremor frequency (DBS OFF - THS ON)
Secondary Outcome
Difference in Tremor Power (DBS OFF-ON)
Occurrence of nystagmus when the stimulation is switched off
Relevant diseases: other cerebellar ataxia, impairment of the affinity to the cerebellum (spinal ataxia, polyneuropathy)
Age
Pallesthesia of the right and left lower extremity
Stimulation parameters (localization, amplitude, frequency, pulse width)
Handling of the stimulation by the patient Demand-adapted reduction of the stimulation during the day (yes vs. no)? night-time reduction of stimulation (yes, night switch-off vs. yes, night-time reduction vs. no)?
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2020/03/10
- 50
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
1. adult patients who have been treated with DBS as part of their essential tremor and who are connected to the Outpatient Clinic for Stereotactic and Functional Neurosurgery at the University Hospital Freiburg
2. written consent
Exclusion Criteria
1. inability to provide informed consent;
2. patients who are no longer able to walk or only able to walk assisted by a walker
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Freiburg Klinik für Neurochirurgie Abteilung Stereotaktische und Funktionelle Neurochirurgie
- Mr. Dr. Bastian Sajonz
- Breisacher Str. 64
- 79106 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +4976127050630
- +4976127050100
- bastian.sajonz at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de/stereotaxie
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinikum Freiburg Klinik für Neurochirurgie Abteilung Stereotaktische und Funktionelle Neurochirurgie
- Mr. Dr. Bastian Sajonz
- Breisacher Str. 64
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +4976127050630
- +4976127050100
- bastian.sajonz at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de/stereotaxie
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinikum Freiburg Klinik für Neurochirurgie Abteilung Stereotaktische und Funktionelle Neurochirurgie
- Mr. Dr. Bastian Sajonz
- Breisacher Str. 64
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +4976127050630
- +4976127050100
- bastian.sajonz at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de/stereotaxie
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsklinikum Freiburg Klinik für Neurochirurgie Abteilung Stereotaktische und Funktionelle Neurochirurgie
- Mr. Dr. Bastian Sajonz
- Breisacher Str. 64
- 79106 Freiburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +4976127050630
- +4976127050100
- bastian.sajonz at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de/stereotaxie
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- [---]*
- [---]*
- 2021/12/20
- 31
- 31
Trial Publications, Results and other Documents
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