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

NCT02588144 | Unknown DMC

• 1 other identifier: IHanci
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 10

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 \[STN+SNr\].

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; freezing of gait; deep brain stimulation; substantia nigra pars reticulata; subthalamic nucleus

Outcome Measures

Primary Outcomes (1)

• Freezing of Gait Assessment Course (FOG-AC)

  Outcome at day 90 (V6) with reference to baseline (V1)

Secondary Outcomes (12)

• Timed Walking test from Core Assessment Program for Surgical Interventions in Parkinson's disease (CAPSIT-PD)

  At baseline, day 2, 8, 21, 42 and 90, respectively

• Berg Balance Scale

  At baseline, day 42 and 90, respectively

• Parkinson's disease questionnaire (PDQ-39)

  At baseline, day 42 and 90, respectively

• Freezing of gait questionnaire

  At baseline, day 42 and 90, respectively

• Beck's depression Inventory

  At baseline, day 42 and 90, respectively

Study Arms (2)

[standard STN]

ACTIVE COMPARATOR

Device: standard stimulation on subthalamic (STN) contacts

Procedure: [standard STN]

[STN+SNr]

EXPERIMENTAL

Device: Combined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr)

Procedure: [STN+SNr]

Interventions

[standard STN] PROCEDURE

High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts

Also known as: subthalamic deep brain stimulation

[standard STN]

[STN+SNr] PROCEDURE

high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation

Also known as: combined subthalamic and nigral stimulation

[STN+SNr]

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Medtronic: collaborator

Study Sites (10)

Center of Neurology and Hertie Institute for Clinical Brain Research, Department for Neurodegenerative Diseases and Neurosurgery University of Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Ludwig-Maximilians-University Munich, Klinikum Großhadern, Department for Neurology and Neurosurgery

Munich, Bavaria, 81377, Germany

RECRUITING

University Hospital Regensburg , Department for Neurology and Neurosurgery

Regensburg, Bavaria, 93053, Germany

RECRUITING

University Hospital Köln, Department for Neurology and Neurosurgery

Cologne, North Rhine-Westphalia, 50924, Germany

RECRUITING

University Hospital of Düsseldorf, Departments for Neurology and Neurosurgery

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

University Hospital Leipzig, Department for Neurology and Neurosurgery

Leipzig, Saxony, 04103, Germany

RECRUITING

University Hospital Kiel, Department for Neurology and Neurosurgery

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Charite- University Hospital Berlin, Departments for Neurology and Neurosurgery

Berlin, 10117, Germany

RECRUITING

University Hospital Hamburg-Eppendorf, Department for Neurology and Neurosurgery

Hamburg, 20246, Germany

RECRUITING

University Hospital Luxembourg, Department for Neurology and Neurosurgery

Luxembourg, L-4362, Luxembourg

RECRUITING

Related Publications (1)

• Weiss D, Walach M, Meisner C, Fritz M, Scholten M, Breit S, Plewnia C, Bender B, Gharabaghi A, Wachter T, Kruger R. Nigral stimulation for resistant axial motor impairment in Parkinson's disease? A randomized controlled trial. Brain. 2013 Jul;136(Pt 7):2098-108. doi: 10.1093/brain/awt122. Epub 2013 Jun 11.

  PMID: 23757762 RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Weiss, MD

CONTACT

0049-7071-29-82340; daniel.weiss@uni-tuebingen.de

Alireza Gharabaghi, MD

CONTACT

0049-7071-29-83550; alireza.gharabaghi@uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 24, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

DE (9); LU (1)