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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

deep brain stimulation (ACTIVA PC, Medtronic)

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, gait, deep brain stimulation, substantia nigra pars reticulata, subthalamic nucleus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

[STNmono]

[STN+SNr]

Arm Description

Conventional stimulation on subthalamic contacts

Combined subthalamic and nigral stimulation

Outcomes

Primary Outcome Measures

'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

Secondary Outcome Measures

CAPSIT-PD

Freezing of gait assessment course

Freezing of gait questionnaire

Berg Balance Scale

Non-motor symptoms scale

Non-motor symptoms quest

Beck's depression scale index

Minnesota Impulsive Disorders Interview

Barratt Impulsiveness Scale

UPDRS I-IV

PDQ-39

Full Information

NCT ID

NCT01355835

First Posted

May 13, 2011

Last Updated

August 7, 2012

Sponsor

University Hospital Tuebingen

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT01355835

Brief Title

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

Acronym

STN/SNr

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Tuebingen

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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].

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Parkinson's disease, gait, deep brain stimulation, substantia nigra pars reticulata, subthalamic nucleus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

[STNmono]

Arm Type

Active Comparator

Arm Description

Conventional stimulation on subthalamic contacts

Arm Title

[STN+SNr]

Arm Type

Experimental

Arm Description

Combined subthalamic and nigral stimulation

Intervention Type

Device

Intervention Name(s)

deep brain stimulation (ACTIVA PC, Medtronic)

Other Intervention Name(s)

Neurostimulation with ACTIVA PC, Medtronic

Intervention Description

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)

Primary Outcome Measure Information:

Title

'Axial score'

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

CAPSIT-PD

Time Frame