Trial document




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  DRKS00023115

Trial Description

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Title

Imaging-based selection of the stimulation parameters of deep brain stimulation in patients with idiopathic Parkinson's syndrome

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Trial Acronym

BiStiP

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URL of the Trial

https://neurocure.de/klinisches-zentrum/forschung-am-ncrc/aktuelle-studien/bistip-studie.html

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Brief Summary in Lay Language

In this study we want to investigate a new approach to postoperative adaptation/optimization of Deep Brain Stimulation (known in German as THS). For this approach, the position of the pacemaker electrodes is determined on the basis of already existing Magnetic Resonance Imaging (MRI) images. Afterwards, a computer program is used to determine which parameters need to be adjusted on the pacemaker in order to achieve the best possible therapeutic effect and at the same time minimize or avoid side effects that may occur due to the propagation of the current into neighboring areas. The effect of the THS achieved with the calculated parameters (setting A) is then evaluated by motor tests. The same tests are also used to determine the effect of the parameters selected by the physician (setting B).

Background: Deep brain stimulation (THS) usually leads to a significant improvement in the clinical picture (e.g. by increasing mobility or improving tremors) and thus usually allows a reduction of dopaminergic medication. In order to achieve the described effects and avoid possible side effects, certain structures must be stimulated as precisely as possible. On the one hand, this was ensured during the operation by precise placement of the electrodes. On the other hand, the THS can be improved by adjusting certain parameters on the pulse generator. Thus, it is possible to regulate both the propagation of the current through the contact surfaces of the respective electrodes and the current pulse itself via its strength, width and frequency. To achieve the best possible clinical outcome of the THS, the treating physician must explore multiple different settings out of a large number of possible parameter combinations. This is a complex and time-consuming process, the success of which depends not only on the skill and experience of the attending physician, but also on the patient's physical condition and cooperation. Since the dopaminergic drugs have to be discontinued before the pacemaker is tested and adjusted, often for several hours, this can be an enormous burden for the patient and the result can be impaired by fatigue effects.

The aim of the study is to show that both settings produce comparable THS effects. To investigate this, 35 patients with THS will be examined. Participation in the study is possible for all adult patients who have not yet had their brain pacemakers adjusted for the first time.

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Brief Summary in Scientific Language

In this prospective, double-blind, randomized, non-inferiority study, an imaging-based algorithm will be used for postoperative optimization of deep brain stimulation (TSH) parameters in patients with idiopathic Parkinson's disease (IPS) to determine the optimal stimulation contact and current based on electrode localization (setting A). These stimulation parameters will then be compared in a crossover design with the parameters determined in the clinical routine (setting B) with regard to their clinical outcome.

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

No

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Description IPD sharing plan:

What data is provided?
Not available

What supporting information is provided, if any?
Not available

Within which time frame will this happen?
not applicable

What will the corresponding procedure be like?
not applicable

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Organizational Data

  •   DRKS00023115
  •   2020/10/05
  •   [---]*
  •   yes
  •   Approved
  •   EA2/117/19, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson disease
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Interventions/Observational Groups

  •   Arm 1: Image-guided stimulation setting. Total electrical current as well as its percental distribution across electrode contacts suggested by algorithm based on electrode reconstructions.
  •   Arm 2: Clinical stimulation setting. Stimulation parameters according to the everyday life setting (minimum past 4 weeks).
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Characteristics

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

The primary endpoint of the study is absolute motor improvement (measured by the overall MDS-UPDRS-III score) compared to motor function without stimulation under the respective stimulation settings. The non-inferiority of setting A compared to setting B is examined by means of a t-test for period differences, a one-sided alpha of 5% and a non-inferiority limit of 5 points. This limit has been defined according to FDA guidelines (Nov 2016) based on clinical considerations.

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Secondary Outcome

Secondary endpoints are motor improvement (ordinal scaled between 0 and 4) and side effect thresholds (measured in mA) as determined in the monopolar review. The contacts are ranked based on these values and the contact sequences are correlated with the contact sequences predicted by the algorithm across cohorts (Spearman correlation). The significance level alpha is 5%.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/09/23
  •   35
  •   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

- Consenting patient
- Minimum age 18 years
- Oral and written informed consent
- Diagnosis of an IPS of the akinetic-rigid or equivalent type according to the criteria of the British Parkinson's Disease Society Brain Bank
- Successful implantation of electrodes for deep brain stimulation in the STN area within the last 2.5 years

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Exclusion Criteria

- Presence of a tremor-dominant subtype according to the criteria of (Stebbins et al., 2013)
- Severe complications, such as bleeding or systemic infection during THS implantation or postoperative course
- Pronounced psychiatric accompanying symptoms (dementia, affective disorders, psychosis)
- Significant limitations of cognitive functions and the ability to express oneself

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Addresses

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    • Charité – Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie, Abteilung Bewegungsstörungen und Neuromodulation
    • Ms.  Prof  Andrea  Kühn 
    • Charitéplatz 1
    • 10115  Berlin
    • Germany
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    • NeuroCure Clinical Research Center (NCRC), Charité - Universitätsmedizin Berlin
    • Charitéplatz 1
    • D-10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie, Abteilung Bewegungsstörungen und Neuromodulation
    • Mr.  Jan  Roediger 
    • Chariteplatz 1
    • 10115  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie, Abteilung Bewegungsstörungen und Neuromodulation
    • Mr.  Jan  Roediger 
    • Charitéplatz 1
    • 10115  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie, Abteilung Bewegungsstörungen und Neuromodulation
    • 10115  Berlin
    • 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.