Trial document




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  DRKS00012931

Trial Description

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Title

Hypogeusia In Vim/DRT-DBS

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Trial Acronym

HIDDen

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URL of the Trial

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Brief Summary in Lay Language

Essential tremor can be treated with Deep Brain Stimulation (DBS), if it does not respond to medication anymore. Leading symptom of essenital tremor is a disturbing trembling of hands. This leads to decreased quality of life, as it interferes for example with eating and drinking, dressing etc.
For DBS therapy electrodes are implanted into a certain region in the brain. Stimulation of this region may lead to improvement of tremor symptoms.
As a side effect, taste disturbances can occur under DBS for essential tremor (and other tremor diseases). Upon deactivation of the stimulation these taste disturbances disappear and therefor these taste disturbances are stimulation-induced. Stimulation-induced taste disturbances are a dilemma, as the stimulation reduces the stigma of tremor patients, so they dare to eat and drink in public again but with an impaired sense of taste. This study aims at determining the cause, frequency and risk-factors of stimulation-induced taste disturbances under DBS for essential tremor. Participating patients will undergo tests of smelling and tasting before and after implantation of the DBS-system. Tremor patients with a planned DBS implantation for tremor in our department can take part in the study.

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Brief Summary in Scientific Language

This is a prospective interventional study examining the cause and frequency of stimulation-induced hypogeusia under thalamic deep brain stimulation (DBS) for tremor. We postulate that stimulation-induced hypogeusia is related to the distance between the volume of activated tissue and the course of the gustatory tract. Participating patients will undergo rhinomanometry, gustometry and olfactometry before and 6-12 months after DBS-implantation. The location of the volume of activated tissue in relation to the gustatory tract will be determined using the stimulation parameters and routine perioperative imaging. The operation itself is not part of the study and will only be performed in patients meeting clinical criteria for indication according to accepted guidelines.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012931
  •   2017/09/08
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  •   yes
  •   Approved
  •   284/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   G25.0 -  Essential tremor
  •   R43.8 -  Other and unspecified disturbances of smell and taste
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Interventions/Observational Groups

  •   Pre-operative gustometry, olfactometry and rhinomanometry prior to implantation of DBS (Deep Brain Stimulation) system. Post-operative gustometry, olfactometry and rhinomanometry 6-12 months after implantation. When post-operative results differ from pre-operative test results gustometry, olfactometry and rhinomanometry will be repeated with DBS stimulator turned OFF.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

To compare gustatory and olfactory function by means of olfactometry and gustometry preoperatively as well as 6-12 months after Implantation of DBS (Deep Brain Stimulation)

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Secondary Outcome

Identification of risk factors for stimulation-induced hypogeusia (age, sex, pre-existing disturbance of olfaction or gustation).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/18
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Adult tremor patients who are being treated with DBS and where DTI imaging data is available. Decision for DBS therapy is made according to standard guidelines outside this study.
2. Written informed consent.

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Exclusion Criteria

1. Patients suffering from multiple sclerosis.
2- Patients with allergies on citric acid or chinine.

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Addresses

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    • Universitätsklinikum FreiburgKlinik für NeurochirurgieAbteilung für Stereotaktische und Funktionelle Neurochirurgie
    • Mr.  Prof. Dr.  Volker  Coenen 
    • Breisacher Str. 64
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum FreibugKlinik für NeurochirurgieAbteilung für Stereotaktische und Funktionelle Neurochirurgie
    • Mr.  Dr.  Bastian  Sajonz 
    • Breisacher Str. 64
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum FreibugKlinik für NeurochirurgieAbteilung für Funktionelle und Stereotaktische Neurochirurgie
    • Mr.  Dr.  Bastian  Sajonz 
    • Breisacher Str. 64
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreibugKlinik für NeurochirurgieAbteilung für Funktionelle und Stereotaktische Neurochirurgie
    • Mr.  Dr.  Bastian  Sajonz 
    • Breisacher Str. 64
    • 79104  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.