Parkinson DiseasePhase 1/2NCT00993291
Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)
A Phase 1/2 study testing Frequency change to 60 Hz and Frequency change to 130 Hz in people with Parkinson Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
In this study the investigators will evaluate the effect of both low and high frequency Deep Brain stimulation of the subthalamic nucleus (STN) in Parkinson's patients who have noted a change in their walking. The investigators' hypothesis is: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Frequency change to 60 Hz and Frequency change to 130 Hz
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be a patient at the Vanderbilt Movement Disorders clinic.
- Report a change in their gait.
- Be able to walk independently when off PD medications for 12-16 hours.
- Have a stable dose of PD medications for the prior three months .
- Not cognitively impaired, so as to give informed consent.
- MMSE > 24.
Who cannot join
- See inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Frequency Change in Bilateral Subthalamic Nucleus (STN)-DBS on Gait Function in PD
In this study the investigators will evaluate the effect of both low and high frequency Deep Brain stimulation of the subthalamic nucleus (STN) in Parkinson's patients who have noted a change in their walking. The investigators' hypothesis is:
- Stimulation at 60 Hertz (Hz) is associated with improved gait with increased stride length and faster time on the Stand walk sit test.
- There is no worsening of the Unified Parkinson's Disease Rating Scale (UPDRS) at 60 Hz.
- Conditions
- Parkinson Disease
- Being tested
- Frequency change to 60 Hz, Frequency change to 130 Hz
- Keywords
- Parkinson's Disease, DBS, Frequency, 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.
Frequency change to 60 HzProcedure or surgery
Also called 60 Hertz
60 Hz stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
Frequency change to 130 HzProcedure or surgery
Also called 130 Hz
130 Hz Stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
| Study group | Role | What they receive |
|---|---|---|
| Baseline frequency | No intervention | Baseline DBS frequency Receives: Procedure: Frequency change to 60 Hz; Procedure: Frequency change to 130 Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stride Length From Baseline
Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length
Measured: 1 hour
Secondary outcomes (2)
Gait Velocity
gait velocity measured as change from baseline in in CM/second
Measured: 5 hours
Time to Walk 14 Meters
Change in the time to walk 14 meters compared to baseline measured in seconds
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fenna Phibbs, Vanderbilt University
- Investigators
- Fenna T Phibbs, MD, Principal investigator, Vanderbilt Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993291
- Sponsor's protocol ID
- 090873
- Status last verified
- Dec 2011
- First submitted
- 8 Oct 2009
- Last updated
- 27 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Frequency Change in Bilateral Subthalamic Nucleus (STN)-DBS on Gait Function in PD
- ClinicalTrials.gov ID
- NCT00993291
- Acronym / sponsor ID
- 090873
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, DBS, Frequency, Deep brain stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Posted 27 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators will evaluate the effect of both low and high frequency Deep Brain stimulation of the subthalamic nucleus (STN) in Parkinson's patients who have noted a change in their walking. The investigators' hypothesis is:
- Stimulation at 60 Hertz (Hz) is associated with improved gait with increased stride length and faster time on the Stand walk sit test.
- There is no worsening of the Unified Parkinson's Disease Rating Scale (UPDRS) at 60 Hz.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline frequency | No intervention | Procedure: Frequency change to 60 Hz, Procedure: Frequency change to 130 HzBaseline DBS frequency |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Be a patient at the Vanderbilt Movement Disorders clinic.
- Report a change in their gait.
- Be able to walk independently when off PD medications for 12-16 hours.
- Have a stable dose of PD medications for the prior three months .
- Not cognitively impaired, so as to give informed consent.
Key exclusion criteria (1 listed)
- See inclusion criteria.
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 |
|---|---|---|
| Frequency change to 60 HzAlso: 60 Hertz60 Hz stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion. | Procedure or surgery | Baseline frequency |
| Frequency change to 130 HzAlso: 130 Hz130 Hz Stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion. | Procedure or surgery | Baseline frequency |
Primary outcome
Change in Stride Length From Baseline
Time frame: 1 hour
Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length
2 secondary outcomes
Gait Velocity
Time frame: 5 hours
Time to Walk 14 Meters
Time frame: 5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Fenna T Phibbs, MD principal investigator
Vanderbilt Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Frequency change to 60 Hz and Frequency change to 130 Hz in people with Parkinson Disease, run by Vanderbilt University 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 1 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 27 Jan 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Stride Length From Baseline (time frame: 1 hour). 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 27 Jan 2012.