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Combined Stimulation of STN and SNr for Resistant Freezing of Gait in Parkinson's Disease (STN+SNr)

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ClinicalTrials.gov Identifier: NCT02588144
Recruitment Status : Unknown
Verified June 2017 by Daniel Weiss, University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : October 27, 2015
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Daniel Weiss, University Hospital Tuebingen

Brief Summary:
54 patients with idiopathic Parkinson's disease and freezing of gait resistant to subthalamic nucleus stimulation and dopaminergic medication will be included into this multicentre randomised controlled double-blinded parallel group clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus [standard STN] as active comparator and (ii) combined stimulation of active electrode contacts located in both the subthalamic nucleus and substantia nigra pars reticulata [STN+SNr].

Condition or disease Intervention/treatment Phase
Parkinson's Disease Procedure: [standard STN] Procedure: [STN+SNr] Not Applicable

Detailed Description:

The primary endpoint of this study is to investigate the efficacy and safety of combined [STN+SNr] stimulation by "interleaving stimulation" as compared to [standardSTN] after 3 months on refractory freezing of gait (FOG). The Trial is designed as superiority study with an 80% power to detect a mean improvement of 4.7 points on the Freezing of Gait Assessment Course (Ziegler et al., 2010) with one-tailed P < 0.2. To this end 54 patients will be studied. After a common baseline assessment in [standardSTN], patients will be randomized to either [standardSTN] or [STN+SNr] in 1:1 ratio (27 per arm). The primary endpoint assessment is scheduled 90 days from baseline assessment (V6). Additional interim visits are scheduled for secondary purpose from baseline at day 2 (V2), day 8 (V3), day 21 (V4), day 42 (V5).

The rationale for this study comes from our previous phase II trial (Weiss et al., 2013) in which we have observed an improvement of freezing of gait from combined STN+SNr stimulation as secondary endpoint compared with standard STN stimulation at three-week follow-up.

Secondary outcome measures include anamnestic assessments on freezing of gait and falls, balance, quality of life, neuropsychiatric symptoms and suicidality.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Stimulation of Subthalamic Nucleus and Substantia Nigra Pars Reticulata for Resistant Freezing of Gait in Parkinson's Disease: A Randomized Controlled Multicenter Trial
Study Start Date : October 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: [standard STN]
Device: standard stimulation on subthalamic (STN) contacts
Procedure: [standard STN]
High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts
Other Name: subthalamic deep brain stimulation

Experimental: [STN+SNr]
Device: Combined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr)
Procedure: [STN+SNr]
high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation
Other Name: combined subthalamic and nigral stimulation




Primary Outcome Measures :
  1. Freezing of Gait Assessment Course (FOG-AC) [ Time Frame: Outcome at day 90 (V6) with reference to baseline (V1) ]

Secondary Outcome Measures :
  1. Timed Walking test from Core Assessment Program for Surgical Interventions in Parkinson's disease (CAPSIT-PD) [ Time Frame: At baseline, day 2, 8, 21, 42 and 90, respectively ]
  2. Berg Balance Scale [ Time Frame: At baseline, day 42 and 90, respectively ]
  3. Parkinson's disease questionnaire (PDQ-39) [ Time Frame: At baseline, day 42 and 90, respectively ]
  4. Freezing of gait questionnaire [ Time Frame: At baseline, day 42 and 90, respectively ]
  5. Beck's depression Inventory [ Time Frame: At baseline, day 42 and 90, respectively ]
  6. Columbia-Suicide Severity Rating Scale [ Time Frame: At baseline, day 42 and 90, respectively ]
  7. Clinical global impression scale [ Time Frame: At day 42 and 90, respectively ]
  8. Falls diary [ Time Frame: At baseline, day 2, 8, 21, 42 and 90, respectively ]
  9. Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS III) [ Time Frame: At baseline, day 2, 8, 21, 42 and 90, respectively ]
  10. Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS II) [ Time Frame: At baseline, day 42 and 90, respectively ]
  11. Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS IV) [ Time Frame: At baseline, day 42 and 90, respectively ]
  12. Freezing of Gait Assessment Course (FOG-AC) [ Time Frame: At baseline, day 2, 8, 21, 42 after active treatment (STN vs. STN+SNr), respectively ]
    To determine treatment kinematics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms
  • Therapy with STN-DBS (deep brain stimulation) (ACTIVA pulse generators) at least six months from surgery
  • Activa PC (Primary Cell) or Activa RC (Rechargeable Cell) as implanted pulse generator with "Interleaving" programming option
  • Localization of an active electrode contact in the subthalamic nucleus
  • Localization of the caudal electrode contacts in the substantia nigra pars reticulata area (coordinates relative to midcommisural Point (MCP):

left: -7mm ≤ x ≤ -12mm; -2mm ≤ y ≤ -6mm; -6mm ≤ z ≤ -10mm right: 7mm ≤ x ≤ 12mm; -2mm ≤ y ≤ -6mm; -6mm ≤ z ≤ -10mm (x = medio-lateral, y = anterio-posterior, z = rostro-caudal)

  • ≥ 30% improvement in UPDRS III with 'standard STN' compared to 'stimulation off' in dopaminergic off
  • Freezing of Gait Assessment Course ≥10 and ≤33
  • Patient not wheelchair-bound and possible to move self-dependently outside a freezing episode.
  • Disease duration ≥ 5 years
  • Age: between 18 and 80 years
  • Dopaminergic medication constant for at least four weeks prior to study enrolment
  • Written informed consent

Exclusion Criteria:

  • Participation in other clinical trials within the past three months and during enrolment in our study
  • Cognitive impairment (Mini Mental State Exam < 20)
  • Suicidality, Psychosis
  • Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
  • Pregnancy
  • Paradoxical levodopa-induced "on" state freezing (Espay et al., 2012)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588144


Contacts
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Contact: Daniel Weiss, MD 0049-7071-29-82340 daniel.weiss@uni-tuebingen.de
Contact: Alireza Gharabaghi, MD 0049-7071-29-83550 alireza.gharabaghi@uni-tuebingen.de

Locations
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Germany
Center of Neurology and Hertie Institute for Clinical Brain Research, Department for Neurodegenerative Diseases and Neurosurgery University of Tübingen Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Daniel Weiss, MD         
Contact: Alireza Gharabaghi, MD         
Ludwig-Maximilians-University Munich, Klinikum Großhadern, Department for Neurology and Neurosurgery Recruiting
Munich, Bayern, Germany, 81377
Contact: Kai Bötzel, MD         
Contact: Jan Mehrkens, MD         
University Hospital Regensburg , Department for Neurology and Neurosurgery Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Josephine Blume, MD         
Contact: Max Lange, MD         
University Hospital of Düsseldorf, Departments for Neurology and Neurosurgery Recruiting
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Contact: Alfons Schnitzler, MD         
Contact: Jan Vesper, MD         
University Hospital Köln, Department for Neurology and Neurosurgery Recruiting
Köln, Nordrhein-Westfalen, Germany, 50924
Contact: Michael Barbe, MD         
Contact: Veerle Visser-Vandewalle, MD         
University Hospital Leipzig, Department for Neurology and Neurosurgery Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: David Weise, MD         
Contact: Dirk Winkler, MD         
University Hospital Kiel, Department for Neurology and Neurosurgery Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Daniela Falk, MD         
Contact: Karsten Witt, MD         
Charite- University Hospital Berlin, Departments for Neurology and Neurosurgery Recruiting
Berlin, Germany, 10117
Contact: Andrea Kühn, MD         
Contact: Gerd-Helge Schneider, MD         
University Hospital Hamburg-Eppendorf, Department for Neurology and Neurosurgery Recruiting
Hamburg, Germany, 20246
Contact: Monika Pötter-Nerger, MD         
Contact: Wolfgang Hamel, MD         
Luxembourg
University Hospital Luxembourg, Department for Neurology and Neurosurgery Recruiting
Luxembourg, Luxembourg, L-4362
Contact: Rejko Krüger, MD         
Contact: Frank Hertel, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Medtronic
Investigators
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Principal Investigator: Daniel Weiss, MD Department for Neurodegenerative Diseases, Centre for Neurology, Tübingen, Germany, and Hertie-Institute for Clinical Brain Research
Principal Investigator: Alireza Gharabaghi, MD Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, Tübingen, Germany, and Center for Integrative Neuroscience, Tübingen, Germany
Publications of Results:
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Responsible Party: Daniel Weiss, MD, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02588144    
Other Study ID Numbers: IHanci
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Keywords provided by Daniel Weiss, University Hospital Tuebingen:
Parkinson's disease
freezing of gait
deep brain stimulation
substantia nigra pars reticulata
subthalamic nucleus
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases