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

NCT00807703 | Completed

• 1 other identifier: MEC 08-2-010
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson; deep brain stimulation (DBS); subthalamic nucleus (STN); Parkinson patients

Outcome Measures

Primary Outcomes (2)

• patients burden

  baseline

• technical feasibility

  baseline

Secondary Outcomes (2)

• Cognition, and in particular impulsivity and affect.

  baseline

• Advantage of fMRI above TMS or double contrast MRI in the planning of the OR.

  baseline

Study Arms (1)

1

EXPERIMENTAL

Select Stim: see summary

Procedure: Select Stim

Interventions

Select Stim PROCEDURE

Select Stim: see summary

1

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

University Hospital Maastricht

Maastricht, Limburg, 6202AZ, Netherlands

Location

Related Links

• Maastricht Institute of Modulative Development

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mark Janssen, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 12, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 17, 2009

Record last verified: 2009-12

Locations

NL (1)