Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease (STN/SNr)

August 7, 2012 updated by: Daniel Weiss, University Hospital Tuebingen

Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease: Design of a Two-armed Double-blind Cross-over Study

12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best individual subthalamic nucleus stimulation and dopaminergic medication will be included into this randomised double-blind cross-over two-armed clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus [STNmono] and (ii) combined stimulation of distant electrode contacts located in the subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata [STN+SNr].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A composite 'axial score' including the major clinical and anamnestic items on gait, posture and balance function from UPDRSII (items 13-15) and UPDRS III (items 27-31) constitutes the primary outcome measure. Secondary outcome measures include specified clinical and anamnestic assessments on freezing of gait, balance, quality of life, non-motor symptoms, impulsivity, impulse control and neuropsychiatric symptoms. The aim of the present trial is to investigate the efficacy and safety of combined stimulation on subthalamic and nigral electrode contacts [STN+SNr] in refractory hypokinetic gait disturbances compared with [STNmono] (active comparator). The results will clarify, whether the combined [STN+SNr] stimulation improves otherwise refractory gait disturbances in PD.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Center of Neurology and Hertie Institute for Clinical Brain Research, and Department for Neurodegenerative Diseases, University of Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Age: between 18 and 80 years
  • Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms and therapy with STN-DBS (ACTIVA pulse generators) at least six months from surgery
  • Optimized subthalamic stimulation at study enrolment (refer 'treatment' section)
  • Gait disturbance refractory on best individual STN-DBS (STNmono) and dopaminergic therapy: 'gait score' in the best clinical [MedOn/STNmono] condition ≥ 12
  • Clinical and image-guided (and facultatively electrophysiological) confirmation of (i) one of the two rostral contacts of the quadripolar electrode localized in the STN area, and (ii) the caudal contacts in the border zone of STN and SNr.
  • Dopaminergic medication constant for at least four weeks prior to study enrolment
  • Disease duration ≥ 5 years

Exclusion Criteria:

  • Cognitive impairment (Mini Mental State Exam < 25)
  • Participation in other clinical trials within the past three months and during enrolment in our study
  • Suicidality, Psychosis
  • Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
  • Pregnancy
  • Acute adverse events from stimulation on contacts in the caudal STN / SNr border interfering with the intended stimulation protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: [STNmono]
Conventional stimulation on subthalamic contacts
Device: deep brain stimulation (ACTIVA PC, Medtronic)
High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude)
Other Names:
  • Neurostimulation with ACTIVA PC, Medtronic
Experimental: [STN+SNr]
Combined subthalamic and nigral stimulation
Device: deep brain stimulation (ACTIVA PC, Medtronic)
High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude)
Other Names:
  • Neurostimulation with ACTIVA PC, Medtronic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
'Axial score'
Time Frame: Three weeks after active treatment (STN vs. STN+SNr), respectively

The composite 'axial score' is built by 8 items from the UPDRS II and III, all 5-point rated (0 to 4) representing increasing levels of pathology. The 'axial score' will be scored by the sum of the ratings across the 8 items (Range 0 to 32). As change in UPDRS scores is a common primary efficacy outcome measure in Parkinson's disease and only items of the original UPDRS are required for the definition of the primary endpoint, the statistical evaluation methods should be based on the psychometric validation of the UPDRS and no own validation studies are necessary.

Safety: falls
Three weeks after active treatment (STN vs. STN+SNr), respectively

Secondary Outcome Measures

Outcome Measure
Time Frame
CAPSIT-PD
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
Freezing of gait assessment course
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
Freezing of gait questionnaire
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
Berg Balance Scale
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
Non-motor symptoms scale
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
Non-motor symptoms quest
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
Beck's depression scale index
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
Minnesota Impulsive Disorders Interview
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
Barratt Impulsiveness Scale
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
UPDRS I-IV
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
PDQ-39
Time Frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively
At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Medtronic

Investigators

  • Principal Investigator: Daniel Weiss, MD, Center of Neurology and Hertie Institute for Clinical Brain Research, and Department for Neurodegenerative Diseases, University of Tübingen
  • Principal Investigator: Rejko Krüger, MD, Center of Neurology and Hertie Institute for Clinical Brain Research, and Department for Neurodegenerative Diseases, University of Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (Estimate)

May 18, 2011

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKF 259-0-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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