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Select Stim: Selective Stimulation of the Subthalamic Nucleus in Parkinson's Disease. "A Feasibility Study"

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00807703
First received: December 11, 2008
Last updated: December 16, 2009
Last verified: December 2009
History of Changes
  Purpose

In the advanced stages of Parkinson Disease deep brain stimulation of the subthalamic nucleus (STN DBS) is the next therapeutic option. Despite the beneficial motor effects there are important negative side-effects of STN DBS. Our hypothesis is that changes in cognition and behavior during STN DBS are related to stimulation of the non-motor parts of the STN.

The primary objective is to avoid cognitive and affective side effects by selective stimulation of the STN motor part.

The main objective of this feasibility study is to measure the patients burden and to test the technical feasibility.

Intervention:

The intervention is an expansion of the classical STN DBS procedure. The targeting using the multichannel registration system by stimulation of the motor cortex and registration of the subthalamic nucleus will be added to the procedure. For this procedure, it is necessary to place a subdural strip under the skull.


Condition Intervention
Parkinson Disease
 Procedure: Select Stim

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Select Stim: Selective Stimulation of the Subthalamic Nucleus in Parkinson's Disease. "A Feasibility Study"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • patients burden [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • technical feasibility [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognition, and in particular impulsivity and affect. [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Advantage of fMRI above TMS or double contrast MRI in the planning of the OR. [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Select Stim: see summary
 Procedure: Select Stim
Select Stim: see summary

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 40-75 years old
  • clinical findings consistent with idiopathic PD
  • suffer from severe response fluctuations and/or dyskinesias,
  • despite optimal drug treatment
  • initially a good response on levodopa.

Exclusion Criteria:

  • psychiatric co-morbidities and cognitive decline, e.g. dementia and psychosis, are excluded from this study.
  • The mini mental state exam (MMSE) score is not allowed to be <24.
  • significant cerebral atrophy,
  • causative factors of PD,
  • multiple white matter lesions or
  • focal brain anomalies
  • Hoehn and Yahr stage of 5 at the best moment of the day.
  • general contra-indications for surgery are considered as exclusion criteria, e.g. coagulopathies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807703

Locations
Netherlands
University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6202AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Mark Janssen, MD Maastricht University Medical Center
  More Information

Additional Information:
Maastricht Institute of Modulative Development  This link exits the ClinicalTrials.gov site
Experimental Neurosurgery group, Maastricht University Hospital  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Prof. Dr. Visser-Vandewalle, MaastrichtUMC
ClinicalTrials.gov Identifier: NCT00807703     History of Changes
Other Study ID Numbers: MEC 08-2-010
Study First Received: December 11, 2008
Last Updated: December 16, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Parkinson
deep brain stimulation (DBS)
subthalamic nucleus (STN)
Parkinson patients

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 18, 2013