Central Nervous System DiseaseLATESTIMNCT02823158
Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM
A study testing Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT) and Best medical treatment in people with Central Nervous System Disease and Basal Ganglia Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's disease (PD). Several controlled randomized studies have given proof of an advantage for operated patients as compared to medically treated patients in terms of motor outcome, activities of daily living and health status. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Central Nervous System Disease, Basal Ganglia Disease, Movement Disorders
- What is being tested?
- Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT) and Best medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2016to Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease according to the UKBB criteria, with the exception that familial forms of otherwise typical parkinsonian syndromes may also be included
- motor complications of dopaminergic medication (dyskinesia or motor fluctuations or both) that are at least moderately bothersome to the patient [on a scale of 5 possible levels: not at all / mildly / moderately / severely / extremely bothersome]
- Presence of at least one of the following absolute exclusion criteria for STN stimulation:
- Mattis dementia rating scale <130 points
- postural instability of >1 in the item of MDS-UPDRS III [item #12] "on" medication
- less than 30% improvement of axial score in the acute levodopa challenge test [axial score =sum of items 3.1, 3.9, 3.10, 3.12, 3.13 of the MDS UPDRS III]
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- or presence of at least two of the following relative exclusion criteria for STN stimulation:
- age > 70 years
- Mattis dementia rating scale <134 points
- gait freezing "on" medication
- dysarthria of > 2 in the item of the MDS-UPDRS III [item #3.1]
- less than 50% improvement of axial score in the acute levodopa challenge test [axial score = sum of items 3.1, 3.9, 3.10, 3.12, 3.13 of the MDS UPDRS III]
- Starkstein apathy score of ≥14
- Complete baseline PDQ-39-SI and patient diary available
- written informed consent
Who cannot join
- Age > 85 years
- surgical or medical contraindications
- abnormalities on brain MRI that preclude the implantation of electrodes into the GPi
- contraindication for 3T MRI (baseline imaging)
- severe medical illness that is likely to hamper the benefit of DBS
- severe personality disorder that may interfere with optimization of DBS
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- dementia according to DSM-V and MMSE < 20
- ongoing psychosis (except pseudohallucinations)
- ongoing major depression (BDI-II > 23) or depression of any severity with suicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial of Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease With Motor Complications and Relative or Absolute Contraindications for Subthalamic Stimulation
Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's disease (PD). Several controlled randomized studies have given proof of an advantage for operated patients as compared to medically treated patients in terms of motor outcome, activities of daily living and health status. However these studies have addressed mostly stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared to best medical treatment (BMT) in a prospective randomized controlled trial in patients with complicated PD who are not good candidates for STN stimulation. The investigators aim assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.
Read the detailed description
The indication and excellent therapeutic effects of STN stimulation have been sufficiently proven in advanced PD, and the contraindications for this treatment are rather well established. Also, the observation that patients fulfilling the "STN-profile" but who had been operated for pallidal DBS and lost part of the treatment's benefit over time, improved when stimulated later in the STN (instead of the GPi) shows that patients qualifying for STN-DBS do not have as good a result with GPi-DBS.
GPi stimulation may be used in patients who do not qualify for STN stimulation. Especially postural instability, age over 70 years, and mild to moderate cognitive deficits are commonly considered to be exclusion criteria for STN stimulation but not for GPi stimulation. Therefore, the investigators propose a prospective randomized controlled trial of GPi stimulation in patients with PD and motor complications who have relative or absolute contraindications for STN stimulation.
- Conditions
- Central Nervous System Disease, Basal Ganglia Disease, Movement Disorders, Neurodegenerative Disorders, Parkinson Disease
- Being tested
- Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT), Best medical treatment
- Keywords
- Parkinson Disease, Morbus Parkinson, Basal Ganglia, Pallidal Stimulation
- Medical subject headings
- Central Nervous System Diseases, Basal Ganglia Diseases, Movement Disorders, Neurodegenerative Diseases, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT)Procedure or surgery
Also called Bilateral pallidal stimulation, Deep brain stimulation
Patients in the GPi group will be implanted with DBS-electrodes within 6 weeks after randomisation. The stimulation parameters and the medical treatment are adjusted for optimal control of motor and non-motor signs and symptoms according to published guidelines using a specified algorithm. The stimulation parameters are recorded at the beginning and at the end of each post-surgical assessment.
Best medical treatment is applied in combination with GPi-DBS.
Best medical treatmentProcedure or surgery
Patients will receive optimized medical treatment according to published evidence based guidelines.
| Study group | Role | What they receive |
|---|---|---|
| GPi DBS and best medical treatment | Experimental | Not described Receives: Procedure: Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT); Procedure: Best medical treatment |
| Best medical treatment | Active comparator | Not described Receives: Procedure: Best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of change of the score of the Parkinson's disease questionnaire 39 (PDQ-39-SI) from baseline to follow-up between the two treatment groups.
Measured: Baseline and 5 months +/- 1 month
Difference of change in number of hours per day spent in motor "on" without troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Measured: Baseline and 5 months +/- 1 month
Secondary outcomes (3)
Difference of change of the score of the MDS-UPDRS part III (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part III) from baseline to follow up between the two trial groups.
Measured: Baseline and 5 months +/- 1 month
Difference of change of the score of the MDS-UPDRS part IV (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part IV) (MDS-UPDRS) from baseline to follow up between the two trial groups.
Measured: Baseline and 5 months +/- 1 month
Difference of change in number of hours per day spent in motor "on" with troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Measured: 5 months +/- 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Michael Schüpbach, PD Dr. med, Principal investigator, Inselspital University Hospital BernInes Debove, Dr. med, Principal investigator, Inselspital University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823158
- Sponsor's protocol ID
- 2016-000334
- Other IDs
- 2016
- Acronym
- LATESTIM
- Status last verified
- Oct 2019
- First submitted
- 18 Apr 2016
- Last updated
- 22 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease With Motor Complications and Relative or Absolute Contraindications for Subthalamic Stimulation
- ClinicalTrials.gov ID
- NCT02823158
- Acronym / sponsor ID
- LATESTIM / 2016-000334
- Conditions
- Central Nervous System Disease, Basal Ganglia Disease, Movement Disorders, Neurodegenerative Disorders, Parkinson Disease
- Keywords
- Parkinson Disease, Morbus Parkinson, Basal Ganglia, Pallidal Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Jul 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.
Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's disease (PD). Several controlled randomized studies have given proof of an advantage for operated patients as compared to medically treated patients in terms of motor outcome, activities of daily living and health status. However these studies have addressed mostly stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared to best medical treatment (BMT) in a prospective randomized controlled trial in patients with complicated PD who are not good candidates for STN stimulation. The investigators aim assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.
Detailed description
The indication and excellent therapeutic effects of STN stimulation have been sufficiently proven in advanced PD, and the contraindications for this treatment are rather well established. Also, the observation that patients fulfilling the "STN-profile" but who had been operated for pallidal DBS and lost part of the treatment's benefit over time, improved when stimulated later in the STN (instead of the GPi) shows that patients qualifying for STN-DBS do not have as good a result with GPi-DBS.
GPi stimulation may be used in patients who do not qualify for STN stimulation. Especially postural instability, age over 70 years, and mild to moderate cognitive deficits are commonly considered to be exclusion criteria for STN stimulation but not for GPi stimulation. Therefore, the investigators propose a prospective randomized controlled trial of GPi stimulation in patients with PD and motor complications who have relative or absolute contraindications for STN stimulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPi DBS and best medical treatment | Experimental | Procedure: Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT), Procedure: Best medical treatment |
| Best medical treatment | Active comparator | Procedure: Best medical treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Parkinson's disease according to the UKBB criteria, with the exception that familial forms of otherwise typical parkinsonian syndromes may also be included
- motor complications of dopaminergic medication (dyskinesia or motor fluctuations or both) that are at least moderately bothersome to the patient [on a scale of 5 possible levels: not at all / mildly / moderately / severely / extremely bothersome]
- Presence of at least one of the following absolute exclusion criteria for STN stimulation:
- or presence of at least two of the following relative exclusion criteria for STN stimulation:
- Complete baseline PDQ-39-SI and patient diary available
Key exclusion criteria (9 listed)
- Age > 85 years
- surgical or medical contraindications
- abnormalities on brain MRI that preclude the implantation of electrodes into the GPi
- contraindication for 3T MRI (baseline imaging)
- severe medical illness that is likely to hamper the benefit of DBS
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 |
|---|---|---|
| Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT)Also: Bilateral pallidal stimulation, Deep brain stimulationPatients in the GPi group will be implanted with DBS-electrodes within 6 weeks after randomisation. The stimulation parameters and the medical treatment are adjusted for optimal control of motor and non-motor signs and symptoms according to published guidelines using a specified algorithm. The stimulation parameters are recorded at the beginning and at the end of each post-surgical assessment. Best medical treatment is applied in combination with GPi-DBS. | Procedure or surgery | GPi DBS and best medical treatment |
| Best medical treatmentPatients will receive optimized medical treatment according to published evidence based guidelines. | Procedure or surgery | Best medical treatment, GPi DBS and best medical treatment |
Primary outcome
Difference of change of the score of the Parkinson's disease questionnaire 39 (PDQ-39-SI) from baseline to follow-up between the two treatment groups.
Time frame: Baseline and 5 months +/- 1 month
Difference of change in number of hours per day spent in motor "on" without troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Time frame: Baseline and 5 months +/- 1 month
3 secondary outcomes
Difference of change of the score of the MDS-UPDRS part III (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part III) from baseline to follow up between the two trial groups.
Time frame: Baseline and 5 months +/- 1 month
Difference of change of the score of the MDS-UPDRS part IV (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part IV) (MDS-UPDRS) from baseline to follow up between the two trial groups.
Time frame: Baseline and 5 months +/- 1 month
Difference of change in number of hours per day spent in motor "on" with troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Time frame: 5 months +/- 1 months
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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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.
Michael Schüpbach, PD Dr. med principal investigator
Inselspital University Hospital Bern
Ines Debove, Dr. med principal investigator
Inselspital University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT) and Best medical treatment in people with Central Nervous System Disease and Basal Ganglia Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 15 inclusion and 9 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: stopped early, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: not enough patients). 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?
Difference of change of the score of the Parkinson's disease questionnaire 39 (PDQ-39-SI) from baseline to follow-up between the two treatment groups. (time frame: Baseline and 5 months +/- 1 month). The study lists 2 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 22 Oct 2019.