Parkinson DiseaseNCT02647372
Deep Brain Stimulation for Parkinson's Disease: the Globus Pallidus Internus Versus Subthalamic Nucleus
A study testing Subthalamic nucleus and Globus pallidus in people with Parkinson Disease, run by Hospital Sirio-Libanes.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Subthalamic nucleus and Globus pallidus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Deep Brain Stimulation for the Treatment of Parkinson's Disease: Comparative Analysis of Clinical Effect of Stimulation of the Globus Pallidus Internus and Subthalamic Nucleus
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.
Read the detailed description
The aim of this retrospective study is to compare motor and non-motor (olfactory, pain, cognition and metabolism) symptoms of the effects of deep brain stimulation target to the nucleus globus pallidus versus the subthalamic nucleus in patients with Parkinson´s disease.
- Conditions
- Parkinson Disease
- Being tested
- Subthalamic nucleus, Globus pallidus
- Keywords
- parkinson, deep brain stimulation, globus pallidus, subthalamic nucleus
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subthalamic nucleusProcedure or surgery
Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus
Globus pallidusProcedure or surgery
Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Subthalamic nucleus; Procedure: 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. Receives: Procedure: Subthalamic nucleus; Procedure: Globus pallidus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological approach measured by UPDRS scale
UPDRS scale before surgery
Measured: through study completion, an average of 2 years
Neurological approach measured by UPDRS scale
UPDRS scale 6 months after surgery
Measured: 6 months
Neurological approach measured by UPDRS scale
UPDRS scale 12 months after surgery
Measured: 12 months
Neurological approach measured by UPDRS scale
UPDRS scale 24 months after surgery
Measured: 24 months
Secondary outcomes (8)
Endocrinological approach
Evaluation of metabolic measures before surgery
Measured: through study completion, an average of 2 years
Endocrinological approach
Evaluation of metabolic measures 6 months after surgery
Measured: 6 months
Endocrinological approach
Evaluation of metabolic measures 12 months after surgery
Measured: 12 months
Endocrinological approach
Evaluation of metabolic measures 24 months after surgery
Measured: 24 months
Endocrinological approach - BMI
Evaluation of body mass index before surgery
Measured: 36 months
Endocrinological approach - BMI
Evaluation of body mass index 6 months after surgery
Measured: 6 months
Endocrinological approach - BMI
Evaluation of body mass index12 months after surgery
Measured: 12 months
Endocrinological approach - BMI
Evaluation of body mass index 24 months after surgery
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJun 2012
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Erich Fonoff, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647372
- Sponsor's protocol ID
- HSL 2012/12
- Status last verified
- Aug 2017
- First submitted
- 10 Nov 2015
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for the Treatment of Parkinson's Disease: Comparative Analysis of Clinical Effect of Stimulation of the Globus Pallidus Internus and Subthalamic Nucleus
- ClinicalTrials.gov ID
- NCT02647372
- Acronym / sponsor ID
- HSL 2012/12
- Conditions
- Parkinson Disease
- Keywords
- parkinson, deep brain stimulation, globus pallidus, subthalamic nucleus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jun 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this retrospective study is to compare motor and non-motor (olfactory, pain, cognition and metabolism) symptoms of the effects of deep brain stimulation target to the nucleus globus pallidus versus the subthalamic nucleus in patients with Parkinson´s disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocrinological approach | Experimental | Procedure: Subthalamic nucleus, Procedure: Globus pallidusParkinson 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. |
| Neurological approach | Experimental | Procedure: Subthalamic nucleus, Procedure: Globus pallidusParkinson patient submitted to DBS surgery target to globus pallidus nucleus or the subthalamic nucleus. Those patients will be neurological evaluation including UPDRS scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subthalamic nucleusSurgery will be performed in 15 patients with DBS target to the subthalamic nucleus | Procedure or surgery | Endocrinological approach, Neurological approach |
| Globus pallidusSurgery will be performed in 15 patients with DBS target to the globus pallidus nucleus | Procedure or surgery | Endocrinological approach, Neurological approach |
Primary outcome
Neurological approach measured by UPDRS scale
Time frame: through study completion, an average of 2 years
UPDRS scale before surgery
Neurological approach measured by UPDRS scale
Time frame: 6 months
UPDRS scale 6 months after surgery
Neurological approach measured by UPDRS scale
Time frame: 12 months
UPDRS scale 12 months after surgery
Neurological approach measured by UPDRS scale
Time frame: 24 months
UPDRS scale 24 months after surgery
8 secondary outcomes
Endocrinological approach
Time frame: through study completion, an average of 2 years
Endocrinological approach
Time frame: 6 months
Endocrinological approach
Time frame: 12 months
Endocrinological approach
Time frame: 24 months
Endocrinological approach - BMI
Time frame: 36 months
Endocrinological approach - BMI
Time frame: 6 months
Endocrinological approach - BMI
Time frame: 12 months
Endocrinological approach - BMI
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Subthalamic nucleus and Globus pallidus in people with Parkinson Disease, run by Hospital Sirio-Libanes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological approach measured by UPDRS scale (time frame: through study completion, an average of 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.