NCT00855621

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
9.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

5.7 years

First QC Date

March 3, 2009

Last Update Submit

November 18, 2016

Conditions

Parkinson's Disease

Keywords

deep brain stimulationsubthalamic nucleus

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (7)

  • Change from baseline of Clinical Dyskinesia Rating Scale score

    12 months

  • Change from baseline in ADL function (UPDRS part II)

    12 months

  • Change from baseline in Mattis Dementia Rating Scale score

    12 months

  • Change in social functioning (Social adjustment scale-SR)

    12 months

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

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Single microelectrode

ACTIVE COMPARATOR

Surgical procedure performed using single microelectrode recording guidance intraoperatively

Procedure: Deep brain stimulation of the subthalamic nucleus

Multiple microelectrode

ACTIVE COMPARATOR

Surgical procedure performed using multiple microelectrode recording guidance intraoperatively

Procedure: Deep brain stimulation of the subthalamic nucleus

Interventions

Deep brain stimulation of the subthalamic nucleusPROCEDURE

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.

Multiple microelectrodeSingle microelectrode

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0027, Norway

Location

Related Publications (1)

  • 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.

    PMID: 30009214DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Espen Dietrichs, MD, PhD

    Department of Neurology, Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant neurologist

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

March 1, 2009

Primary Completion

November 1, 2014

Study Completion

December 1, 2023

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

NO(1)