NCT01355835

Brief Summary

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 \[STN+SNr\].

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

1.5 years

First QC Date

May 13, 2011

Last Update Submit

August 7, 2012

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasegaitdeep brain stimulationsubstantia nigra pars reticulatasubthalamic nucleus

Outcome Measures

Primary Outcomes (1)

  • 'Axial score'

    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 Outcomes (11)

  • CAPSIT-PD

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

  • Freezing of gait assessment course

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

  • Freezing of gait questionnaire

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

  • Berg Balance Scale

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

  • Non-motor symptoms scale

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

  • +6 more secondary outcomes

Study Arms (2)

[STNmono]

ACTIVE COMPARATOR

Conventional stimulation on subthalamic contacts

Device: deep brain stimulation (ACTIVA PC, Medtronic)

[STN+SNr]

EXPERIMENTAL

Combined subthalamic and nigral stimulation

Device: deep brain stimulation (ACTIVA PC, Medtronic)

Interventions

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)

Also known as: Neurostimulation with ACTIVA PC, Medtronic
[STN+SNr][STNmono]

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (2)

  • Weiss D, Breit S, Wachter T, Plewnia C, Gharabaghi A, Kruger R. Combined stimulation of the substantia nigra pars reticulata and the subthalamic nucleus is effective in hypokinetic gait disturbance in Parkinson's disease. J Neurol. 2011 Jun;258(6):1183-5. doi: 10.1007/s00415-011-5906-3. Epub 2011 Feb 2. No abstract available.

    PMID: 21287187BACKGROUND

  • Weiss D, Wachter T, Meisner C, Fritz M, Gharabaghi A, Plewnia C, Breit S, Kruger R. Combined STN/SNr-DBS for the treatment of refractory gait disturbances in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2011 Oct 11;12:222. doi: 10.1186/1745-6215-12-222.

    PMID: 21989388DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 18, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

DE(1)