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Effects of Deep Brain Stimulation in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status

Active

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Deep brain stimulation of the subthalamic nucleus

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring deep brain stimulation, subthalamic nucleus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Parkinson's disease
Symptoms ≥ 5 years
Severity of Parkinson's disease ≥ 20 points in UPDRS motor scale (scale 0-108) in OFF medication state
Marked fluctuations of motor symptoms AND/OR troublesome dyskinesias AND/OR severe tremor AND/OR intolerable side-effects of dopaminergic drugs
Failure of medical treatment to sufficiently control symptoms
L-dopa responsive symptoms with ≥30% reduction in UPDRS motor score in drug ON state compared to OFF state OR severe l-dopa unresponsive tremor

Exclusion Criteria:

Previous surgery for Parkinson's disease
Marked axial motor symptoms unresponsive to treatment with l-dopa
Dementia (Mattis dementia rating scale < 130).
Patient suffering from untreated moderate or major depression or anxiety disorder
Presence of other psychiatric disorder preventing necessary co-operation
Brain MRI showing marked atrophy or white matter changes
Increased risk of bleeding
Presence of medical illness with short life expectancy
Other surgical contra-indications

Sites / Locations

Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Single microelectrode

Multiple microelectrode

Arm Description

Surgical procedure performed using single microelectrode recording guidance intraoperatively

Surgical procedure performed using multiple microelectrode recording guidance intraoperatively

Outcomes

Primary Outcome Measures

Change from baseline of the motor score of the New-UPDRS (part III) OFF medication

Secondary Outcome Measures

Change from baseline of Clinical Dyskinesia Rating Scale score

Change from baseline in ADL function (UPDRS part II)

Change from baseline in Mattis Dementia Rating Scale score

Change in social functioning (Social adjustment scale-SR)

Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life)

Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index)

Frequency of new or worsened psychiatric symptoms

Full Information

NCT ID

NCT00855621

First Posted

March 3, 2009

Last Updated

November 18, 2016

Sponsor

Oslo University Hospital

Collaborators

South-Eastern Norway Regional Health Authority

1. Study Identification

Unique Protocol Identification Number

NCT00855621

Brief Title

Effects of Deep Brain Stimulation in Parkinson's Disease

Official Title

Prognostic Factors in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) - a Prospective Randomized Double-blind Study (The NORSTIM Study)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 2009 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

South-Eastern Norway Regional Health Authority

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to identify factors predicting good results in patients treated with deep brain stimulation for Parkinson's disease. The study includes a comparison of two surgical methods used to provide this therapy.

Detailed Description

The study will prospectively examine the effects of deep brain stimulation of the subthalamic nucleus (STN-DBS) on motor function, quality of life and cognitive function in Parkinson's disease (PD) patients treated at Rikshospitalet University Hospital. The aim is to identify which factors that predict good treatment outcome, in order to improve patient selection of this generally highly effective, but specialized and expensive treatment. The study has several aims: Randomized double-blind evaluation of the impact of using single vs. multiple electrode-recordings to guide electrode placement. To identify factors predicting good effect on motor function and improvements of quality of life after deep brain stimulation of the subthalamic nucleus. To identify cognitive and psychiatric changes related to deep brain stimulation of the subthalamic nucleus To study social functioning of patients after STN-DBS and quality of life of patient caregivers

6. Conditions and Keywords

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

Parkinson's Disease

Keywords

deep brain stimulation, subthalamic nucleus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single microelectrode

Arm Type

Active Comparator

Arm Description

Surgical procedure performed using single microelectrode recording guidance intraoperatively

Arm Title

Multiple microelectrode

Arm Type

Active Comparator

Arm Description

Surgical procedure performed using multiple microelectrode recording guidance intraoperatively

Intervention Type

Procedure

Intervention Name(s)

Deep brain stimulation of the subthalamic nucleus

Intervention Description

Chronic bilateral deep brain stimulation in the nucleus subthalamicus is performed using the most effective of four electrode contacts identified during testing of stimulation settings. Stimulation settings will be variable and adjusted according to the symptoms of each individual patient. Stimulation parameters will be recorded at each individual examination. Dopaminergic and other necessary medication will be given according to the need of each patient.

Primary Outcome Measure Information:

Title

Change from baseline of the motor score of the New-UPDRS (part III) OFF medication

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change from baseline of Clinical Dyskinesia Rating Scale score

Time Frame

12 months

Title

Change from baseline in ADL function (UPDRS part II)

Time Frame

12 months

Title

Change from baseline in Mattis Dementia Rating Scale score

Time Frame

12 months

Title

Change in social functioning (Social adjustment scale-SR)

Time Frame

12 months

Title

Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life)

Time Frame

12 months

Title

Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index)

Time Frame

12 months

Title

Frequency of new or worsened psychiatric symptoms

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Parkinson's disease Symptoms ≥ 5 years Severity of Parkinson's disease ≥ 20 points in UPDRS motor scale (scale 0-108) in OFF medication state Marked fluctuations of motor symptoms AND/OR troublesome dyskinesias AND/OR severe tremor AND/OR intolerable side-effects of dopaminergic drugs Failure of medical treatment to sufficiently control symptoms L-dopa responsive symptoms with ≥30% reduction in UPDRS motor score in drug ON state compared to OFF state OR severe l-dopa unresponsive tremor Exclusion Criteria: Previous surgery for Parkinson's disease Marked axial motor symptoms unresponsive to treatment with l-dopa Dementia (Mattis dementia rating scale < 130). Patient suffering from untreated moderate or major depression or anxiety disorder Presence of other psychiatric disorder preventing necessary co-operation Brain MRI showing marked atrophy or white matter changes Increased risk of bleeding Presence of medical illness with short life expectancy Other surgical contra-indications

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Espen Dietrichs, MD, PhD

Organizational Affiliation

Department of Neurology, Oslo University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

ZIP/Postal Code

0027

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

30009214

Citation

Bjerknes S, Toft M, Konglund AE, Pham U, Waage TR, Pedersen L, Skjelland M, Haraldsen I, Andersson S, Dietrichs E, Skogseid IM. Multiple Microelectrode Recordings in STN-DBS Surgery for Parkinson's Disease: A Randomized Study. Mov Disord Clin Pract. 2018 May 8;5(3):296-305. doi: 10.1002/mdc3.12621. eCollection 2018 May-Jun.

Results Reference

derived

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Effects of Deep Brain Stimulation in Parkinson's Disease

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