Parkinson's Disease With Deep Brain StimulationNCT02080572
Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS
An observational study of Parkinson's Disease With Deep Brain Stimulation, run by Great Lakes NeuroTechnologies Inc. at 2 sites in United States.
Trial summary
Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson's Disease With Deep Brain Stimulation
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Dec 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Parkinson's disease, gait impairment, and deep brain stimulation will be recruited.
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease
- Age > 21
- Underwent DBS surgery targeting the subthalamic nucleus (STN)
- Bilateral or midline involvement when "off" DBS/medication state
- Clinical history of gait impairment or freezing of gait
Who cannot join
- "Parkinson's plus" syndrome, secondary, or atypical Parkinson's disease
- Underwent DBS surgery targeting the ventral intermediate (VIM)
- Unable to walk independent of a wheelchair (use of assistive devices, like a cane, is okay for this study)
- Dementia (determined by a neuropsychological assessment).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45220
University Hospitals of Case Western
Cleveland, Ohio, 44106
About this study
Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. This study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with DBS tuning for the lower extremities and gait in the future.
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 |
|---|---|---|
| Parkinson's Disease with DBS | Individuals with Parkinson's disease and deep brain stimulation will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of DBS cessation on motor function over time
Motor function evaluations (movement speed and magnitude) will be collected at various time points after DBS cessation. The effects over time will be examined.
Measured: All data will be collected within a single session not to exceed 4 hours. All data will be analyzed within one month of study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease With Deep Brain StimulationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center, University of Cincinnati, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Joseph P Giuffrida, PhD, Principal investigator, Great Lakes NeuroTechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080572
- Sponsor's protocol ID
- AG033947-03A1
- Other IDs
- 2R44AG033947-03A1
- Status last verified
- Feb 2015
- First submitted
- 4 Mar 2014
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS
- ClinicalTrials.gov ID
- NCT02080572
- Acronym / sponsor ID
- AG033947-03A1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center, University of Cincinnati, National Institute on Aging (NIA)
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 6 Mar 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.
Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. This study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with DBS tuning for the lower extremities and gait in the future.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease with DBS | – | –Individuals with Parkinson's disease and deep brain stimulation will be recruited. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Parkinson's disease, gait impairment, and deep brain stimulation will be recruited.
Key inclusion criteria (5 listed)
- Diagnosis of idiopathic Parkinson's disease
- Age > 21
- Underwent DBS surgery targeting the subthalamic nucleus (STN)
- Bilateral or midline involvement when "off" DBS/medication state
- Clinical history of gait impairment or freezing of gait
Key exclusion criteria (4 listed)
- "Parkinson's plus" syndrome, secondary, or atypical Parkinson's disease
- Underwent DBS surgery targeting the ventral intermediate (VIM)
- Unable to walk independent of a wheelchair (use of assistive devices, like a cane, is okay for this study)
- Dementia (determined by a neuropsychological assessment).
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
Effect of DBS cessation on motor function over time
Time frame: All data will be collected within a single session not to exceed 4 hours. All data will be analyzed within one month of study completion.
Motor function evaluations (movement speed and magnitude) will be collected at various time points after DBS cessation. The effects over time will be examined.
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 5 Feb 2015.
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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.
Joseph P Giuffrida, PhD principal investigator
Great Lakes NeuroTechnologies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease With Deep Brain Stimulation, run by Great Lakes NeuroTechnologies Inc. at 2 sites 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 5 inclusion and 4 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 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Effect of DBS cessation on motor function over time (time frame: All data will be collected within a single session not to exceed 4 hours. All data will be analyzed within one month of study completion.). 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 5 Feb 2015.