Trial document





This trial has been registered retrospectively.
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  DRKS00012667

Trial Description

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Title

Bipolar directional stimulation to reduce side-effects in deep brain stimulation of the thalamus

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Trial Acronym

BiDirect

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URL of the Trial

http://N/A

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Brief Summary in Lay Language

This Study investigates wether Patients with tremor and deep brain stimulation with a new so-called 'directional' lead can profit from a special stimulation setting. We investigate wether this setting can help to reduce side-effects and lead to an improved effect on the tremor.

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Brief Summary in Scientific Language

We hypothesized that bipolarity in directional Deep Brain Stimulation (DBS) leads to a wider therapeutic window. This study investigates in detail wether DBS with directional leads and a bipolar directional setting has advantages compared to monopolar or conventional bipolar stimulation regarding side-effect thresholds and tremor suppression. We investigate patients with parkinsonian or essential tremor which have been implanted inside the thalamus or the posterior subthalamic area.

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Organizational Data

  •   DRKS00012667
  •   2017/07/24
  •   [---]*
  •   yes
  •   Approved
  •   17-044, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   G25 -  Other extrapyramidal and movement disorders
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Interventions/Observational Groups

  •   Monopolar stimulation:
    each patient will be programmed consecutively and in a randomized order in the following different stimulation-settings: monopolar stimulation, conventional bipolar stimulation, bipolar directional stimulation
    The conditions will be compared regarding the treshold for side effects and the effect on the tremor

  •   conventional bipolar stimulation:
    each patient will be programmed consecutively and in a randomized order in the following different stimulation-settings: monopolar stimulation, conventional bipolar stimulation, bipolar directional stimulation
    The conditions will be compared regarding the treshold for side effects and the effect on the tremor
  •   directional bipolar stimulation:
    each patient will be programmed consecutively and in a randomized order in the following different stimulation-settings: monopolar stimulation, conventional bipolar stimulation, bipolar directional stimulation
    The conditions will be compared regarding the treshold for side effects and the effect on the tremor
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Comparison of side-effect thresholds between 1. monopolar, 2. conventional bipolar, and 3. directional bipolar stimulation.

Prim. Outcome: immediate treshold (in mA) of side effects in the different stimulation settings during a monopolar review

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Secondary Outcome

Comparison of effect on tremor of 1. monopolar, 2. conventional bipolar, and 3. directional bipolar stimulation.
Sec. Outcome: Tremor Rating Scale Total Score of patient when stimulating just below the treshold of side effects, 15 minutes after the stimulation ist programmed

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/04/27
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- Diagnosis of essential tremor or tremordominant Parkinson's disease
- Implantation of DBS-electrodes in the Ventral intermediate nucleus thalami (VIM) for at least 3 months
- Age between 18 and 80 years
- Full understanding of all study related procedures and ability to sign the written informed consent

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Exclusion Criteria

- no withdrawal of medication over night possible
- dementia or other relevant cognitive impairment

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Addresses

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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Mr.  Dr.  Michael T.  Barbe 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Ms.  Julia K.  Steffen 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • 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.