Parkinsons DiseaseGKSTNNCT02249559
Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease
An observational study of Parkinsons Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a pilot study to evaluate the safety and efficacy of unilateral gamma knife subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain stimulation. Read more about this study
- Who is it for?
- Ages 74 years and older
- Conditions the study is for
- Parkinsons Disease
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2017
- Phase
- Observational
- 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 74 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Primary care clinic
Who may be able to join
- Otherwise appropriate DBS candidates but deemed suboptimal for DBS on account of one or more of the following:
- advanced age greater than 74 years of age
- medical comorbidities
- need for continual anticoagulation
- poor candidates for general anesthesia based on cardiac, hepatic ,renal or pulmonary status
- high infection risk if internal DBS device hardware is placed (ie. Poor diabetes mellitus control)
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- patient aversion to DBS
- Patients with asymmetric disease symptoms including:
- rigidity
- tremor
- bradykinesia
- dyskinesia
- More than 30% improvement in UPDRS score in ON versus OFF medication state, except:
- in the presence of disabling contralateral dyskinesias/dystonia limiting dose tolerance
- tremors that are medically refractory
- Patients who are on a stable medication regimen and demonstrating stable disease symptoms (absence of significant improvement or deterioration) for at least 3 months at the time of GKS, as determined by review of medical record
- MMSE score greater than or equal to 26
Who cannot join
- Patients with prominent axial symptoms including postural instability and gait disturbances, defined as a score of 3 or greater on Questions 28, 29 \& 30 on the UPDRS
- Patients whose symptoms do not improve by more than 30% in UPDRS score with medication, unless patient experiences dose-limiting side effects
- The presence of dementia or inability to provide informed consent for participation in the study, as determined by a mini-mental status examination score below 25
- Patients who have had prior brain radiation
- Patients with improvement and satisfactory symptom management will not be offered this procedure. We will only include patients without satisfactory symptom management.
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study to evaluate the safety and efficacy of unilateral gamma knife subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain stimulation.
Read the detailed description
The goal of the study is to enroll 20 subjects who could benefit from unilateral subthalamotomy due to the presence of unilateral rigidity, tremor, bradykinesia and/or dyskinesias (as opposed to axial symptoms such as walking) but who are suboptimal candidates for deep brain stimulation (DBS) because of advanced age (>74), medical comorbidities precluding surgery, or patient aversion to DBS, and who show more than 30% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) score in the ON versus OFF medication state.
Secondary objectives will focus on the efficacy of Gamma Knife (GK) subthalamotomy for Parkinson's disease (PD), as determined by changes in the patient's clinical status and any improvement following the treatment. A full neurologic exam as well as a screen for depression will be administered at every postoperative visit. The patient's neurologic function will be assessed with a full neurological examination and objectively quantified using the UPDRS focusing on the contralateral side, as well as overall UPDRS.
The clinician will complete a Clinical Global Impression (CGI) and Mini-Mental State Examination (MMSE) at each visit to record overall impression of the patient's disease progression and severity, and to evaluate cognitive function. Pre- and post-treatment assessment of the Levodopa Equivalent Daily Dose (LEDD) (quantification of medication regimen in levodopa equivalents) will be obtained and recorded to evaluated the efficacy of gamma knife subthalamotomy (GKS) as a treatment for Parkinson's disease (PD). A Parkinson's Disease Questionnaire-39 (PDQ-39) to determine the patient's independence and quality of life will be filled out at each visit. Finally, the patient will complete a Beck Depression Inventory at each clinic visit to monitor for development or progression of depressive symptoms.
- Conditions
- Parkinsons Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GK subthalamotomy | Evaluate the safety and efficacy of unilateral GK subthalamotomy for PD in patients deemed poor candidates for DBS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of performing GK lesions in the Subthalamic Nucleus (STN) for PD patients
- Safety of GK subthalamotomy in the management of PD as measured by stable findings on neurologic exam at each clinic visit (hemiballismus, dyskinesias, sensory changes) and the absence of Serious Adverse Events (SAE) attributable to treatment.
- Because this study does not have a control group, we will compare the non-inferiority of GK subthalamotomy to published outcomes in PD patients undergoing other forms of management.
Measured: 12 months
Secondary outcomes (1)
Efficacy of GK subthalamotomy for PD
To be determined by changes in the patient's clinical status and any improvement following the treatment.
- Neurologic function as determined by UPDRS, MMSE, neurologic exam results, CGI assessment and LEDD score.
- Quality of life, as determined by PDQ-39 score and Beck's Depression Inventory (BDI) score.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Kondziolka, MD, Principal investigator, NYU MEDICAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249559
- Sponsor's protocol ID
- 14-00902
- Acronym
- GKSTN
- Status last verified
- Dec 2017
- First submitted
- 12 Sep 2014
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02249559
- Acronym / sponsor ID
- GKSTN / 14-00902
- Conditions
- Parkinsons Disease
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Sep 2014 (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 is a pilot study to evaluate the safety and efficacy of unilateral gamma knife subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain stimulation.
Detailed description
The goal of the study is to enroll 20 subjects who could benefit from unilateral subthalamotomy due to the presence of unilateral rigidity, tremor, bradykinesia and/or dyskinesias (as opposed to axial symptoms such as walking) but who are suboptimal candidates for deep brain stimulation (DBS) because of advanced age (>74), medical comorbidities precluding surgery, or patient aversion to DBS, and who show more than 30% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) score in the ON versus OFF medication state.
Secondary objectives will focus on the efficacy of Gamma Knife (GK) subthalamotomy for Parkinson's disease (PD), as determined by changes in the patient's clinical status and any improvement following the treatment. A full neurologic exam as well as a screen for depression will be administered at every postoperative visit. The patient's neurologic function will be assessed with a full neurological examination and objectively quantified using the UPDRS focusing on the contralateral side, as well as overall UPDRS.
The clinician will complete a Clinical Global Impression (CGI) and Mini-Mental State Examination (MMSE) at each visit to record overall impression of the patient's disease progression and severity, and to evaluate cognitive function. Pre- and post-treatment assessment of the Levodopa Equivalent Daily Dose (LEDD) (quantification of medication regimen in levodopa equivalents) will be obtained and recorded to evaluated the efficacy of gamma knife subthalamotomy (GKS) as a treatment for Parkinson's disease (PD). A Parkinson's Disease Questionnaire-39 (PDQ-39) to determine the patient's independence and quality of life will be filled out at each visit. Finally, the patient will complete a Beck Depression Inventory at each clinic visit to monitor for development or progression of depressive symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GK subthalamotomy | – | –Evaluate the safety and efficacy of unilateral GK subthalamotomy for PD in patients deemed poor candidates for DBS. |
Who may qualify
- Ages
- 74 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Primary care clinic
Key inclusion criteria (17 listed)
- Otherwise appropriate DBS candidates but deemed suboptimal for DBS on account of one or more of the following:
- Patients with asymmetric disease symptoms including:
- More than 30% improvement in UPDRS score in ON versus OFF medication state, except:
- Patients who are on a stable medication regimen and demonstrating stable disease symptoms (absence of significant improvement or deterioration) for at least 3 months at the time of GKS, as determined by review of medical record
- MMSE score greater than or equal to 26
Key exclusion criteria (5 listed)
- Patients with prominent axial symptoms including postural instability and gait disturbances, defined as a score of 3 or greater on Questions 28, 29 \& 30 on the UPDRS
- Patients whose symptoms do not improve by more than 30% in UPDRS score with medication, unless patient experiences dose-limiting side effects
- The presence of dementia or inability to provide informed consent for participation in the study, as determined by a mini-mental status examination score below 25
- Patients who have had prior brain radiation
- Patients with improvement and satisfactory symptom management will not be offered this procedure. We will only include patients without satisfactory symptom management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of performing GK lesions in the Subthalamic Nucleus (STN) for PD patients
Time frame: 12 months
* Safety of GK subthalamotomy in the management of PD as measured by stable findings on neurologic exam at each clinic visit (hemiballismus, dyskinesias, sensory changes) and the absence of Serious Adverse Events (SAE) attributable to treatment. * Because this study does not have a control group, we will compare the non-inferiority of GK subthalamotomy to published outcomes in PD patients undergoing other forms of management.
1 secondary outcome
Efficacy of GK subthalamotomy for PD
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
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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.
Douglas Kondziolka, MD principal investigator
NYU MEDICAL CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinsons Disease, run by NYU Langone Health at 1 site in United States.
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 17 inclusion and 5 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 6 Dec 2017. 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 United States. 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. 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?
Safety of performing GK lesions in the Subthalamic Nucleus (STN) for PD patients (time frame: 12 months). 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 6 Dec 2017.