Parkinsons DiseaseNCT02569021
Battery-preserving Stimulation Patterns for Deep Brain Stimulation
An observational study of Parkinsons Disease and Essential Tremor, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to test effectiveness of different deep brain stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the battery. If these patterns are effective, the implanted batteries will be drained more slowly and last longer than currently expected. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinsons Disease, Essential Tremor
- What is being tested?
- Biphasic DBS stimulation, Unified Parkinson's Disease Rating Scale and Tremor Rating Scale
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited during routine DBS programming sessions at the University of Florida, Center for Movement Disorders
Who may be able to join
- Diagnosis of Parkinson's disease or Essential Tremor by strict criteria
- Deep brain stimulation (DBS) already implanted
- Optimized Deep brain stimulation (DBS) settings (or at least 4 months of DBS programming)
Who cannot join
- Other neurological diagnoses (co-existent Alzheimer's or ALS)
- No Deep brain stimulation (DBS)
- less than 4 Deep brain stimulation (DBS) programming
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
About this study
Official title: Battery-preserving Stimulation Patterns to Improve Symptoms in Parkinson's Disease and Essential Tremor
The purpose of this research study is to test effectiveness of different deep brain stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the battery. If these patterns are effective, the implanted batteries will be drained more slowly and last longer than currently expected. An increase in battery life may reduce the number of surgeries needed to replace them.
Read the detailed description
Deep brain stimulation (DBS) is an effective surgical therapy for medication-refractory symptoms of Parkinson's disease, tremor, and dystonia. Patients implanted with DBS experience a significant improvement of their symptoms with relatively low risk of intolerable side effects. Implanted patients must undergo repeat surgeries to replace the Implantable Pulse Generators/batteries (IPG) approximately every 2 to 5 years. The DBS program (at the University of Florida) has studied battery consumption and has been interested in potential strategies to extend the life of the IPG to reduce the need for frequent battery replacement surgeries, while improving symptom-relief, patient satisfaction, and the potential associated financial burdens.
The research study will evaluate the effects of novel stimulation patterns on tremor, bradykinesia, rigidity and gait in Parkinson's disease and essential tremor patients.
- Conditions
- Parkinsons Disease, Essential Tremor
- Being tested
- Biphasic DBS stimulation, Unified Parkinson's Disease Rating Scale, Tremor Rating Scale, Kinesia accelerometer, Trigno wireless system
- Keywords
- Parkinsons Disease, Essential Tremor, DBS, Depp Brain Stimulation
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic DBS stimulationDevice
The following protocol will be followed for each subject. In between, baseline and novel stimulation settings there will be a 30-minute washout period with DBS in the off state.
- Current best/optimized DBS setting (considered "baseline")
- DBS off for 30 minutes as a washout period
- Biphasic pulse stimulation mode (assessment at 0.5hr)
- Biphasic pulse stimulation mode (assessment at 1hr)
- Biphasic pulse stimulation mode (assessment at 2hr)
- Biphasic pulse stimulation mode (assessment at 3hr)
Unified Parkinson's Disease Rating ScaleOther
Also called UPDRS
UPDRS is used by neurologists to rate the motor impairment of people with Parkinson's Disease.
Tremor Rating ScaleOther
Also called TRS
TRS is used by neurologists to rate the severity of a tremor.
Kinesia accelerometerDevice
The kinesia accelerometer is used to analyze the tremor and slowness (bradykinesia) of the participants.
Trigno wireless systemDevice
The Trigno system measure muscle contractions.
GaitRite walking assessment.Other
GaitRite records a patients gait pattern.
| Study group | Role | What they receive |
|---|---|---|
| Biphasic DBS stimulations | Subjects in this group will have Biphasic DBS stimulation setting performed, Unified Parkinson's Disease Rating Scale (UPDRS), Tremor Rating Scale (TRS), kinesia accelerometer assessment, Trigno wireless system (EMG) assessment and GaitRite walking assessment performed. Receives: Device: Biphasic DBS stimulation; Other: Unified Parkinson's Disease Rating Scale; Other: Tremor Rating Scale; Device: Kinesia accelerometer; Device: Trigno wireless system; Other: GaitRite walking assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of novel stimulation patterns by the Unified Parkinson's Disease Rating Scale
The Unified Parkinson's Disease Rating Scale (UPDRS) is used by neurologists to rate the motor impairment of people with Parkinson's Disease. The rater obtains the score by observation and questioning the participant. Higher scores represent greater impairment and scores range from 0-108. The subject will be videotaped and two raters blinded to conditions will score the UPDRS.
Measured: Baseline to Day 1
Evaluate the efficacy of novel stimulation patterns by the Tremor Rating Scale
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity. The subjet will be videotaped and two raters blinded to conditions will score the TRS.
Measured: Baseline to Day 1
Kinesia accelerometer to measure motor dysfunction
The Kinesia system includes a unit worn by the subject and software that is used to collect, manage, and analyze data. The system measures three-dimensional motion using three orthogonal accelerometers and three orthogonal gyroscopes located in the sensor module.The digital data is received by the Receiver connected to a computer and processed by the Kinesia software package.
Measured: Baseline to Day 1
Trigno wireless system to measure motor dysfunction
This system has sensors with a multi-function design and therefore along with recording of surface EMG signal, it allows Triaxial Accelerometry. This wireless EMG machine will measure muscle contractions.
Measured: Baseline to Day 1
GaitRite walking assessment.
The GaitRite is an automated floor that when the subjects walk on the floor it records the gait pattern.
Measured: Baseline to Day 1
Secondary outcomes (1)
Battery Consumption compared between pre and post settings
Battery consumption will be calculated and compared between the new settings and subjects' baseline settings. The Medtronic battery estimator helpline will be used to calculate battery life, as well as the University of Florida calculator.
Measured: Baseline to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startMay 2014
- Primary completionApr 2016
- Study completionSep 2016
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 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Micheal Okun, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569021
- Sponsor's protocol ID
- IRB201501030
- Status last verified
- Oct 2016
- First submitted
- 2 Oct 2015
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Battery-preserving Stimulation Patterns to Improve Symptoms in Parkinson's Disease and Essential Tremor
- ClinicalTrials.gov ID
- NCT02569021
- Acronym / sponsor ID
- IRB201501030
- Conditions
- Parkinsons Disease, Essential Tremor
- Keywords
- Parkinsons Disease, Essential Tremor, DBS, Depp Brain Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Oct 2015 (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 purpose of this research study is to test effectiveness of different deep brain stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the battery. If these patterns are effective, the implanted batteries will be drained more slowly and last longer than currently expected. An increase in battery life may reduce the number of surgeries needed to replace them.
Detailed description
Deep brain stimulation (DBS) is an effective surgical therapy for medication-refractory symptoms of Parkinson's disease, tremor, and dystonia. Patients implanted with DBS experience a significant improvement of their symptoms with relatively low risk of intolerable side effects. Implanted patients must undergo repeat surgeries to replace the Implantable Pulse Generators/batteries (IPG) approximately every 2 to 5 years. The DBS program (at the University of Florida) has studied battery consumption and has been interested in potential strategies to extend the life of the IPG to reduce the need for frequent battery replacement surgeries, while improving symptom-relief, patient satisfaction, and the potential associated financial burdens.
The research study will evaluate the effects of novel stimulation patterns on tremor, bradykinesia, rigidity and gait in Parkinson's disease and essential tremor patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biphasic DBS stimulations | – | Device: Biphasic DBS stimulation, Other: Unified Parkinson's Disease Rating Scale, Other: Tremor Rating Scale, Device: Kinesia accelerometer, Device: Trigno wireless system, Other: GaitRite walking assessment.Subjects in this group will have Biphasic DBS stimulation setting performed, Unified Parkinson's Disease Rating Scale (UPDRS), Tremor Rating Scale (TRS), kinesia accelerometer assessment, Trigno wireless system (EMG) assessment and GaitRite walking assessment performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited during routine DBS programming sessions at the University of Florida, Center for Movement Disorders
Key inclusion criteria (3 listed)
- Diagnosis of Parkinson's disease or Essential Tremor by strict criteria
- Deep brain stimulation (DBS) already implanted
- Optimized Deep brain stimulation (DBS) settings (or at least 4 months of DBS programming)
Key exclusion criteria (3 listed)
- Other neurological diagnoses (co-existent Alzheimer's or ALS)
- No Deep brain stimulation (DBS)
- less than 4 Deep brain stimulation (DBS) programming
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 |
|---|---|---|
| Biphasic DBS stimulationThe following protocol will be followed for each subject. In between, baseline and novel stimulation settings there will be a 30-minute washout period with DBS in the off state. 1. Current best/optimized DBS setting (considered "baseline") 2. DBS off for 30 minutes as a washout period 3. Biphasic pulse stimulation mode (assessment at 0.5hr) 4. Biphasic pulse stimulation mode (assessment at 1hr) 5. Biphasic pulse stimulation mode (assessment at 2hr) 6. Biphasic pulse stimulation mode (assessment at 3hr) | Device | Biphasic DBS stimulations |
| Unified Parkinson's Disease Rating ScaleAlso: UPDRSUPDRS is used by neurologists to rate the motor impairment of people with Parkinson's Disease. | Other | Biphasic DBS stimulations |
| Tremor Rating ScaleAlso: TRSTRS is used by neurologists to rate the severity of a tremor. | Other | Biphasic DBS stimulations |
| Kinesia accelerometerThe kinesia accelerometer is used to analyze the tremor and slowness (bradykinesia) of the participants. | Device | Biphasic DBS stimulations |
| Trigno wireless systemThe Trigno system measure muscle contractions. | Device | Biphasic DBS stimulations |
| GaitRite walking assessment.GaitRite records a patients gait pattern. | Other | Biphasic DBS stimulations |
Primary outcome
Evaluate the efficacy of novel stimulation patterns by the Unified Parkinson's Disease Rating Scale
Time frame: Baseline to Day 1
The Unified Parkinson's Disease Rating Scale (UPDRS) is used by neurologists to rate the motor impairment of people with Parkinson's Disease. The rater obtains the score by observation and questioning the participant. Higher scores represent greater impairment and scores range from 0-108. The subject will be videotaped and two raters blinded to conditions will score the UPDRS.
Evaluate the efficacy of novel stimulation patterns by the Tremor Rating Scale
Time frame: Baseline to Day 1
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity. The subjet will be videotaped and two raters blinded to conditions will score the TRS.
Kinesia accelerometer to measure motor dysfunction
Time frame: Baseline to Day 1
The Kinesia system includes a unit worn by the subject and software that is used to collect, manage, and analyze data. The system measures three-dimensional motion using three orthogonal accelerometers and three orthogonal gyroscopes located in the sensor module.The digital data is received by the Receiver connected to a computer and processed by the Kinesia software package.
Trigno wireless system to measure motor dysfunction
Time frame: Baseline to Day 1
This system has sensors with a multi-function design and therefore along with recording of surface EMG signal, it allows Triaxial Accelerometry. This wireless EMG machine will measure muscle contractions.
GaitRite walking assessment.
Time frame: Baseline to Day 1
The GaitRite is an automated floor that when the subjects walk on the floor it records the gait pattern.
1 secondary outcome
Battery Consumption compared between pre and post settings
Time frame: Baseline to Day 1
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 24 Oct 2016.
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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.
Micheal Okun, M.D. 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?
An observational study of Parkinsons Disease and Essential Tremor, 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 3 inclusion and 3 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 24 Oct 2016. 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?
Evaluate the efficacy of novel stimulation patterns by the Unified Parkinson's Disease Rating Scale (time frame: Baseline to Day 1). The study lists 5 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 24 Oct 2016.