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NCT Number: NCT01355835

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

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].

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Tübingen, Baden-Wurttemberg, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

deep brain stimulation (ACTIVA PC, Medtronic)

Device

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

Primary outcomes

  1. '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

Secondary outcomes

  1. CAPSIT-PD

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  2. Freezing of gait assessment course

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  3. Freezing of gait questionnaire

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  4. Berg Balance Scale

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  5. Non-motor symptoms scale

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  6. Non-motor symptoms quest

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  7. Beck's depression scale index

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  8. Minnesota Impulsive Disorders Interview

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  9. Barratt Impulsiveness Scale

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  10. UPDRS I-IV

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

  11. PDQ-39

    Time frame: At baseline and three weeks after active treatment (STN vs. STN+SNr), respectively

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: STN/SNr

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 18, 2011
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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