Parkinsons DiseaseNCT02318927
A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease
A study testing Deep Brain Stimulation in people with Parkinsons Disease, run by University of Florida at 1 site in United States.
Trial summary
The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication freezing of gait (FoG) in Parkinsons Disease (PD). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinsons Disease
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 26 Sep 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of idiopathic PD, without a previous DBS operation
- Must be deemed appropriate for a GPi DBS operation by the interdisciplinary screening team (GPi must be the target chosen as most appropriate for treatment of their PD to qualify for this study)
- Age 30-75 years (must meet UK Brain Bank criteria for diagnosis of idiopathic Parkinson's disease).
- Experiencing significant gait and postural instability despite optimal pharmacologic management (Hoehn and Yahr Stage II or greater in the on state). 5. Best medication "on" does not reveal meaningful improvement in posture scores (Pull Test). Patients must be challenged in person with a suprathreshold dose of levodopa (1.5 times optimized regular dose of levodopa) and must have poor or no improvement in postural stability.
- 6. Patients must possess a clinical history of gait freezing > 2 episodes per month, to be included, participants must also score > 1 on item #3 of the Freezing of Gait (FOG) Questionnaire and exhibit five or more FoG episodes during the provocation protocol in on or off state.
- 7. L-dopa responsive with clearly defined "on" periods. 8. Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.
Who cannot join
- Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications. Clinically significant medical disease includes uncontrolled systemic hypertension with values above 170/100mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
- Evidence of secondary or atypical parkinsonism.
- Other neurological and musculoskeletal impairments that would negatively influence postural stability
- Past MRI scan with significant evidence of brain atrophy or other abnormalities. 5. Dementia as evidenced by impairment in two neuropsychological domains and a Mattis Dementia Score <130.
- 6. A major untreated psychiatric disorder as revealed on psychiatric exam at screening, and a Beck Depression Inventory Score >14.
- 7. Subjects with a history of seizures. 8. Subjects who may require repeat MRI scans. 9. Subjects with a history of a cranial neurosurgical procedure. 10. Subjects with metal in the head or another implanted stimulator (e.g. vagus nerve stimulator, spinal cord stimulator, pacemaker, cochlear implant, etc).
- 11. Subjects who require treatment with Electroconvulsive therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS).
- 12. Pregnant or nursing women or women who wish to become pregnant will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
About this study
The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from these two brain regions after surgery will allow for the development of a personalized DBS system to address FoG. The primary outcome will be a comparison of the pre-operative number of FoG episodes in the laboratory during the FoG battery versus those 6 months post-DBS at the optimized device settings.
Read the detailed description
As a participant in the study you will have the following procedure performed:
A series of questions by interview, questionnaires, and checklists will be collected. In addition, basic information (such as age, sex, race) and psychiatric, medical, and family history, physical and neurological exam that will include measuring vital signs (heart rate and blood pressure). There will be a "Falls Diary' to complete (an account of falling incidents and the details). Specific testing will be done to evaluate the gait and balance which will be repeated throughout the study. A psychiatric evaluation of mood and emotion will be performed including a detailed psychological testing, consisting of perception, learning, and memory. These psychological assessments will be repeated at every study visit. An MRI and a CT scan will be performed to make sure of the exact location of the DBS implant. The study will end in 24 months.
- Conditions
- Parkinsons Disease
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Freezing of Gait (FoG) episodes in the laboratory during the FoG battery
Measured: Change from Baseline to 6 Months
Secondary outcomes (1)
Number of adverse events (AE's) .
The DSMB will review all adverse events (AE's) in real time. The device related AE definition will include both therapy and procedure related AE's. The Data Safety Monitoring Board (DSMB) will evaluate the study at least every 6 months and have the power to terminate the study for safety reasons.
Measured: Change from Baseline to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion3 Nov 2016
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinsons DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Michael S Okun, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318927
- Sponsor's protocol ID
- IRB201400951
- Status last verified
- Sep 2018
- First submitted
- 12 Dec 2014
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Molina R, Hass CJ, Sowalsky K, Schmitt AC, Opri E, Roper JA, Martinez-Ramirez D, Hess CW, Foote KD, Okun MS, Gunduz A. Neurophysiological Correlates of Gait in the Human Basal Ganglia and the PPN Region in Parkinson's Disease. Front Hum Neurosci. 2020 Jun 4;14:194. doi: 10.3389/fnhum.2020.00194. eCollection 2020.
PubMed 32581744Tahafchi P, Molina R, Roper JA, Sowalsky K, Hass CJ, Gunduz A, Okun MS, Judy JW. Freezing-of-Gait detection using temporal, spatial, and physiological features with a support-vector-machine classifier. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:2867-2870. doi: 10.1109/EMBC.2017.8037455.
PubMed 29060496
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02318927
- Acronym / sponsor ID
- IRB201400951
- Conditions
- Parkinsons Disease
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Medtronic, Michael J. Fox Foundation for Parkinson's Research
- Study start
- Jan 2015 (actual)
- Primary completion
- 3 Nov 2016 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 17 Dec 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.
The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from these two brain regions after surgery will allow for the development of a personalized DBS system to address FoG. The primary outcome will be a comparison of the pre-operative number of FoG episodes in the laboratory during the FoG battery versus those 6 months post-DBS at the optimized device settings.
Detailed description
As a participant in the study you will have the following procedure performed:
A series of questions by interview, questionnaires, and checklists will be collected. In addition, basic information (such as age, sex, race) and psychiatric, medical, and family history, physical and neurological exam that will include measuring vital signs (heart rate and blood pressure). There will be a "Falls Diary' to complete (an account of falling incidents and the details). Specific testing will be done to evaluate the gait and balance which will be repeated throughout the study. A psychiatric evaluation of mood and emotion will be performed including a detailed psychological testing, consisting of perception, learning, and memory. These psychological assessments will be repeated at every study visit. An MRI and a CT scan will be performed to make sure of the exact location of the DBS implant. The study will end in 24 months.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Device: Deep Brain StimulationDeep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A clinical diagnosis of idiopathic PD, without a previous DBS operation
- Must be deemed appropriate for a GPi DBS operation by the interdisciplinary screening team (GPi must be the target chosen as most appropriate for treatment of their PD to qualify for this study)
- Age 30-75 years (must meet UK Brain Bank criteria for diagnosis of idiopathic Parkinson's disease).
- Experiencing significant gait and postural instability despite optimal pharmacologic management (Hoehn and Yahr Stage II or greater in the on state). 5. Best medication "on" does not reveal meaningful improvement in posture scores (Pull Test). Patients must be challenged in person with a suprathreshold dose of levodopa (1.5 times optimized regular dose of levodopa) and must have poor or no improvement in postural stability.
- 6. Patients must possess a clinical history of gait freezing > 2 episodes per month, to be included, participants must also score > 1 on item #3 of the Freezing of Gait (FOG) Questionnaire and exhibit five or more FoG episodes during the provocation protocol in on or off state.
Key exclusion criteria (8 listed)
- Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications. Clinically significant medical disease includes uncontrolled systemic hypertension with values above 170/100mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
- Evidence of secondary or atypical parkinsonism.
- Other neurological and musculoskeletal impairments that would negatively influence postural stability
- Past MRI scan with significant evidence of brain atrophy or other abnormalities. 5. Dementia as evidenced by impairment in two neuropsychological domains and a Mattis Dementia Score <130.
- 6. A major untreated psychiatric disorder as revealed on psychiatric exam at screening, and a Beck Depression Inventory Score >14.
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 StimulationDeep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams. | Device | Deep Brain Stimulation |
Primary outcome
Number of Freezing of Gait (FoG) episodes in the laboratory during the FoG battery
Time frame: Change from Baseline to 6 Months
1 secondary outcome
Number of adverse events (AE's) .
Time frame: Change from Baseline to 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 32581744Molina R, Hass CJ, Sowalsky K, Schmitt AC, Opri E, Roper JA, Martinez-Ramirez D, Hess CW, Foote KD, Okun MS, Gunduz A. Neurophysiological Correlates of Gait in the Human Basal Ganglia and the PPN Region in Parkinson's Disease. Front Hum Neurosci. 2020 Jun 4;14:194. doi: 10.3389/fnhum.2020.00194. eCollection 2020.
- Derived from this study: PubMed 29060496Tahafchi P, Molina R, Roper JA, Sowalsky K, Hass CJ, Gunduz A, Okun MS, Judy JW. Freezing-of-Gait detection using temporal, spatial, and physiological features with a support-vector-machine classifier. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:2867-2870. doi: 10.1109/EMBC.2017.8037455.
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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 S Okun, MD principal investigator
University of Florida
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 in people with Parkinsons Disease, run by University of Florida 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 6 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: finished, as of the sponsor's last update on 28 Sep 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Freezing of Gait (FoG) episodes in the laboratory during the FoG battery (time frame: Change from Baseline to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02318927, which also lists 2 linked publications.
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 28 Sep 2018.