Trial document



drksid header

  DRKS00020967

Trial Description

start of 1:1-Block title

Title

Stimulation Induced ceREbellar syndrome after VIM/DRT-DBS – the SIREN-Study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

SIREN

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00020967
  •   2020/02/28
  •   [---]*
  •   yes
  •   Approved
  •   623/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G25.0 -  Essential tremor
  •   G46.4 -  Cerebellar stroke syndrome
end of 1:N-Block indications
start of 1:N-Block interventions

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
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   [---]*
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary factor to be investigated is the difference in tremor frequency (DBS OFF - THS ON)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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)?

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/03/10
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

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-sponsor
    start of 1:1-Block address contact primary-sponsor
    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-contact
    start of 1:1-Block address contact scientific-contact
    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-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

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 materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   [---]*
  •   [---]*
  •   2021/12/20
  •   31
  •   31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.