Trial document




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  DRKS00010783

Trial Description

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Title

Directional Stimulation in Parkinson’s Disease

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Trial Acronym

DISPLAy

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study will include patients suffering from Parkinson's disease (PD) who will be treated with deep brain stimulation (DBS). Diagnosis and indication for DBS treatment as well as the implantation of the DBS system will be performed in clinical routine. Within this therapy a new technological option shall be used. Until now a circular field is created around the electrode. Beside the target region also other brain regions are stimulated and this leads to adverse effects. The new form of the directional stimulation allows to adapt the stimulation field with a very high accuracy. Thus, it seems possible to stimulate the target regions only without stimulation of other unwanted brain regions. As a result fewer adverse events are expected. With this new kind of stimulation the number of possible combination of electrode contacts raises rapidly. The usual method of finding the optimal contacts and parameter settings is the so-called intraoprative testing; this means individual testing of each contact. Due to the aforementioned high number of contacts this is linked to high efforts and some burdens for the patient. To determine the optimal contacts faster, it is possible to perform intraoperative recordings via the implanted electrodes. Based on these recordings the so-called "beta-activity" can be identified and the optimal contacts can be determined. The trial is divided into two parts:
- The general feasibility of the method to identify the optimal contacts and stimulation parameters shall be assessed in a validation trial in 6 patients.
- In a subsequent randomized part the results of the validation trial shall be used to compare the new method of identification of the optimal stimulation settings to the conventional method (intraoperative testing).

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Brief Summary in Scientific Language

All study participants will receive deep brain stimulation (DBS) for treatment of Parkinson's disease (PD) and therefore there will be no disadvantages for study participants concerning routine treatment.

In the conventional DBS method circular electrical are created around the electrode. This leads to stimulation of the target region but also to stimulation of unwanted regions and subsequent to adverse events. Exact positioning of electrodes may lead to stimulation mainly in the target region; nevertheless stimulation of unwanted brain regions cannot be excluded.

The directional stimulation is a new method where no circular impulses are emitted around the electrode but where the field of electric stimulation can be controlled. For example it is possible that only brain regions rostral of the electrode are stimulated. This field can be modified in almost any size and direction. Therefore it seems possible to stimulate the target regions only and to avoid stimulation of other brain regions; it is expected that fewer adverse events will occur.

This new kind of stimulation requires a huge number of possible stimulator configurations. Up to eight contacts per side can be activated in various combinations. The conventional testing of each available contact (monopolar review) is time-consuming. Patients must stop their PD medication for the monopolar review and therefore this testing is burdensome for patients.

In a validation study a new method for finding optimal stimulation parameters will be tested: during surgery recordings of the electrical activity via micro- and macroelectrodes will be performed for localization of the target region. A PD-typical correlate, excessive activity in beta frequency range, was identified. This study aims to evaluate whether identification of beta-activity in recordings via the directional electrode is feasible. Those contacts, where strong beta-activity is measured, shall be activated test-wise for stimulation. In addition the effect on motor performance will be evaluated.

The results of the validation trial shall then be tested in a randomized trial in 12 patients where acute followed by chronic stimulation will be applied. In this setting the new method of beta-activation will be compared to the conventional monopolar review.

Better identification of target brain regions is expected due to determination of beta-activity. It is also expected that directional stimulation leads to fewer adverse events.

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Organizational Data

  •   DRKS00010783
  •   2016/11/22
  •   [---]*
  •   yes
  •   Approved
  •   401/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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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

  •   12 patients will be randomized into group 1 and group 2 and will receive deep brain stimulation paradigms in the following order:

    Group 1:
    Acute A (monopolar review)
    Acute B (intraoperative testing)
    Chronic A (monopolar review, DBS for 8 weeks)
    Chronic B (intraoperative testing, DBS for 8 weeks)
  •   12 patients will be randomized into group 1 and group 2 and will receive deep brain stimulation paradigms in the following order:

    Group 2:
    Acute B (monopolar review)
    Acute A (intraoperative testing)
    Chronic B (monopolar review, DBS for 8 weeks)
    Chronic A (intraoperative testing, DBS for 8 weeks)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Therapeutic width of a directed current paradigm compared to a conventional (“spherical”) stimulation

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Secondary Outcome

- Therapeutic widths of directed current paradigms (conventional (“spherical”) mode stimulation, stimulation based on a computational model of an optimal electric field, electrophysiology-based stimulation paradigm).
- Unified Parkinson’s Disease rating scale (UPDRS) Part III (Stim On, Med Off) immediately after programming of the DBS-System. For this assessment, an amplitude will be selected that is just below the threshold of side effects (including On-state dyskinesia).
- UPDRS Part III (Stim On, Med. On) after 4 weeks for each paradigm (spherical mode stimulation, modulation of the electric field based on a computational model, modulation of the electric field based on intraoperative electrophysiological measurements)
- Description of side effects

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/05/23
  •   18
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   75   Years
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Additional Inclusion Criteria

1. Male or female patients aged ≥35 and ≤ 75 years
2. Patients with the diagnosis of Parkinson’s disease according to the criteria of the British PD Brain Bank. Parkinson patients are included with a prominent hypokinetic-rigid component of their disease and beginning or severe motor fluctuations
3. Disease duration ≥ 4 years
4. Written informed consent
5. UPDRS part III (off) 30-50

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Exclusion Criteria

1. Major Depression with suicidal thoughts or suicidal thoughts in history
2. Signs of dementia in neuropsychological testing (part of clinical routine assessment)
3. Acute psychosis stated by a psychiatric physician
4. Nursing care at home
5. Unable to give written informed consent
6. Surgical contraindications
7. Medications that are likely to cause interactions in the opinion of the investigator
8. Known or persistent abuse of medication, drugs or alcohol
9. Current or planned pregnancy, nursing period

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Addresses

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    • Universitätsklinikum FreiburgKlinik für NeurochirurgieAbteilung für Steroetaktische und Funktionelle Neurochirurgie
    • Mr.  Dr. med.  Peter  Reinacher 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für NeurochirurgieAbteilung für Stereotaktische und Funktionelle Neurochirurgie
    • Mr.  Dr. med.  Peter  Reinacher 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
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    • Universitätsklinikum FreiburgKlinik für NeurochirurgieAbteilung für Stereotaktische und Funktionelle Neurochirurgie
    • Mr.  Dr. med.  Peter  Reinacher 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgKlinik für NeurochirurgieAbteilung für Stereotaktische und Funktionelle Neurochirurgie
    • Mr.  Dr. med.  Peter  Reinacher 
    • Breisacher Str. 64
    • 79106  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.