NCT02647372

Brief Summary

This study provides an evaluation of 30 patients in 3 years, from the Unified Health System (SUS) irrespective of region of the country, signed with clinical Parkinson's disease in its intermediate stage and that the drug therapy is limited by side effects or beneficial effects provided by prior medication no longer be obtained even at high doses and have therefore the indication for treatment with deep brain stimulation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable parkinson-disease

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

June 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

5.5 years

First QC Date

November 10, 2015

Last Update Submit

August 15, 2017

Conditions

Parkinson Disease

Keywords

parkinsondeep brain stimulationglobus pallidussubthalamic nucleus

Outcome Measures

Primary Outcomes (4)

  • Neurological approach measured by UPDRS scale

    UPDRS scale before surgery

    through study completion, an average of 2 years

  • Neurological approach measured by UPDRS scale

    UPDRS scale 6 months after surgery

    6 months

  • Neurological approach measured by UPDRS scale

    UPDRS scale 12 months after surgery

    12 months

  • Neurological approach measured by UPDRS scale

    UPDRS scale 24 months after surgery

    24 months

Secondary Outcomes (8)

  • Endocrinological approach

    through study completion, an average of 2 years

  • Endocrinological approach

    6 months

  • Endocrinological approach

    12 months

  • Endocrinological approach

    24 months

  • Endocrinological approach - BMI

    36 months

  • +3 more secondary outcomes

Study Arms (2)

Endocrinological approach

EXPERIMENTAL

Parkinson patient submitted to DBS surgery target to globus pallidus nucleus or the subthalamic nucleus. Those patients will be endocrinological evaluation including metabolic measures, calorimetric parameters.

Procedure: Subthalamic nucleusProcedure: Globus pallidus

Neurological approach

EXPERIMENTAL

Parkinson patient submitted to DBS surgery target to globus pallidus nucleus or the subthalamic nucleus. Those patients will be neurological evaluation including UPDRS scale.

Procedure: Subthalamic nucleusProcedure: Globus pallidus

Interventions

Subthalamic nucleusPROCEDURE

Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus

Endocrinological approachNeurological approach
Globus pallidusPROCEDURE

Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus

Endocrinological approachNeurological approach

Eligibility Criteria

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

You may qualify if:

  • Patients with a clinical diagnosis of idiopathic Parkinson's disease according to the international criteria that have not responded adequately to treatment with medication or who have complications related to prolonged use of L-dopa.
  • Patients who may be in the anesthetized or local or general anesthesia does not incur higher than expected risk in the general population.
  • Patients intellectually able to understand and sign the consent form.
  • Patients with hematological, metabolic and normal coagulation.

You may not qualify if:

  • Age below 18 years
  • Impossibility to consent to participate in the study.
  • Patients during treatment with anti-coagulants or anti-platelet agents.
  • Patients with anatomical abnormalities that preclude access to the implantation of electrodes (eg cranial tumors or intracranial or cysts).
  • Patients with uncontrolled infection or other medical conditions pre-existing non-controlled (eg decompensated diabetes, hypertension, heart disease or symptomatic air).
  • History of primary or secondary myocardial ischemia, congestive heart failure, cardiac arrhythmia or bundle branch block refractory to treatment.
  • Concomitant treatment with other experimental drugs.
  • Pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 10, 2015

First Posted

January 6, 2016

Study Start

June 1, 2012

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

August 17, 2017

Record last verified: 2017-08