Parkinson's DiseaseNCT01909531
Deep Brain Stimulation (DBS) Data Base Study
An observational study of Parkinson's Disease and Essential Tremor, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
The primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection, targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Essential Tremor
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 31 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's Disease or Essential Tremor who have undergone either awake or asleep DBS surgery performed by Francisco A. Ponce, MD
Who may be able to join
- Clinical diagnosis for Parkinson's Disease or Essential Tremor
- Subject has undergone DBS surgery
Who cannot join
- Clinical diagnosis for Parkinson's Disease or Essential Tremor
- Subject has not undergone DBS surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital & Medical Center / Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
The primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection, targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor.
Read the detailed description
Deep Brain Stimulation (DBS) surgery is a treatment that can improve some of the motor symptoms associated with several movement disorder diseases. DBS is recommended for patients with Parkinson's disease who respond well to medication, but still experience frequent wearing off of medications with return of symptoms. Patients may also be experiencing troubling medication side effects such as dyskinesias, sleepiness, hallucinations, confusion, and behavioral/personality changes. DBS is also used for patients with Essential tremor who have undergone long trials of medication therapy and are still symptomatic. The goal of DBS surgery is to capture that best response to medication and hold it through the day. The Food and Drug Administration (FDA) approved DBS as a treatment for essential tremor in 1997 and for Parkinson's disease in 2002.
The goal of DBS surgery is to improve the quality of life of patients and their families by reducing motor symptoms such as slowness, stiffness and tremor and possibly reducing medication. In order to help with our understanding of its effects, we will collect information on patients who will be undergoing or have undergone DBS surgery.
St. Joseph's Hospital and Medical Center / Barrow Neurological Institute is one of only a few hospitals in the United States offering a new procedure known as asleep DBS surgery, performed under general anesthesia, as well as the traditional awake DBS procedure; therefore it is important that this new asleep surgery option be studied and compared to awake DBS surgery.
Objectives include:
- Comparison of data collected for both the awake and asleep DBS procedures during the pre-operative and post-operative periods including testing, diagnosis, surgical treatment, target accuracy, complications, motor function and quality of life outcomes.
- Comparison of the differential effects of STN and GPi DBS on gait and balance control
- Investigate the effects of DBS on the saccadic eye movements.
- Conditions
- Parkinson's Disease, Essential Tremor
- Keywords
- Deep Brain Stimulation, Parkinsons Disease, Essential Tremor, Asleep DBS
- Medical subject headings
- Parkinson Disease, Essential Tremor
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Comparison
Data comparison for pre-operative testing, diagnosis, surgical treatment, target accuracy, complications and outcomes for patients undergoing DBS surgery will be analyzed.
Measured: Pre-operative through 6 months post operative
Secondary outcomes (1)
Quantitative Evaluation of Balance and Gait
For the quantitative evaluation of gait and balance control, different parameters of gait and balance will be obtained non-invasively during pre- and post-surgical clinical evaluation sessions. For this data collection, patients will be asked to perform many trials of quiet standing (eyes open and eyes closed conditions), postural shifts, stepping-in-place, and regular and tandem walking. These data will be obtained using a portable gait system (consisted of small light-weight sensors) and force plate setup. During balance tests, the patients will be asked to hold on to railings in case of loss of balance and asked to wear gait belt during these evaluations. A member of the research team will be close to the patient to hold them in case of any loss of balance to avoid falls.
Measured: Pre-operative through 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startApr 2013
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco A Ponce, MD, Principal investigator, St. Joseph's Hospital & Medical Center / Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909531
- Sponsor's protocol ID
- 12BN136
- Status last verified
- Sep 2021
- First submitted
- 24 Jul 2013
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation (DBS) Data Base Study
- ClinicalTrials.gov ID
- NCT01909531
- Acronym / sponsor ID
- 12BN136
- Conditions
- Parkinson's Disease, Essential Tremor
- Keywords
- Deep Brain Stimulation, Parkinsons Disease, Essential Tremor, Asleep DBS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Jul 2013 (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 primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection, targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor.
Detailed description
Deep Brain Stimulation (DBS) surgery is a treatment that can improve some of the motor symptoms associated with several movement disorder diseases. DBS is recommended for patients with Parkinson's disease who respond well to medication, but still experience frequent wearing off of medications with return of symptoms. Patients may also be experiencing troubling medication side effects such as dyskinesias, sleepiness, hallucinations, confusion, and behavioral/personality changes. DBS is also used for patients with Essential tremor who have undergone long trials of medication therapy and are still symptomatic. The goal of DBS surgery is to capture that best response to medication and hold it through the day. The Food and Drug Administration (FDA) approved DBS as a treatment for essential tremor in 1997 and for Parkinson's disease in 2002.
The goal of DBS surgery is to improve the quality of life of patients and their families by reducing motor symptoms such as slowness, stiffness and tremor and possibly reducing medication. In order to help with our understanding of its effects, we will collect information on patients who will be undergoing or have undergone DBS surgery.
St. Joseph's Hospital and Medical Center / Barrow Neurological Institute is one of only a few hospitals in the United States offering a new procedure known as asleep DBS surgery, performed under general anesthesia, as well as the traditional awake DBS procedure; therefore it is important that this new asleep surgery option be studied and compared to awake DBS surgery.
Objectives include:
- Comparison of data collected for both the awake and asleep DBS procedures during the pre-operative and post-operative periods including testing, diagnosis, surgical treatment, target accuracy, complications, motor function and quality of life outcomes.
- Comparison of the differential effects of STN and GPi DBS on gait and balance control
- Investigate the effects of DBS on the saccadic eye movements.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease or Essential Tremor who have undergone either awake or asleep DBS surgery performed by Francisco A. Ponce, MD
Key inclusion criteria (2 listed)
- Clinical diagnosis for Parkinson's Disease or Essential Tremor
- Subject has undergone DBS surgery
Key exclusion criteria (2 listed)
- Clinical diagnosis for Parkinson's Disease or Essential Tremor
- Subject has not undergone DBS surgery
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
Data Comparison
Time frame: Pre-operative through 6 months post operative
Data comparison for pre-operative testing, diagnosis, surgical treatment, target accuracy, complications and outcomes for patients undergoing DBS surgery will be analyzed.
1 secondary outcome
Quantitative Evaluation of Balance and Gait
Time frame: Pre-operative through 6 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
Francisco A Ponce, MD principal investigator
St. Joseph's Hospital & Medical Center / Barrow Neurological Institute
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 Parkinson's Disease and Essential Tremor, run by St. Joseph's Hospital and Medical Center, Phoenix 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. 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?
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?
Data Comparison (time frame: Pre-operative through 6 months post operative). 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 16 Sep 2021.