Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fenna Phibbs, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00993291
First received: October 8, 2009
Last updated: December 21, 2011
Last verified: December 2011
Results First Received: August 22, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Procedure: Frequency change to 60 Hz
Procedure: Frequency change to 130 Hz

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Baseline Frequency Gait analysis at the subjects baseline DBS frequency

Participant Flow:   Overall Study
    Baseline Frequency  
STARTED     20  
COMPLETED     19  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Baseline Frequency Gait analysis at the subjects baseline DBS frequency

Baseline Measures
    Baseline Frequency  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  62  ± 5.54  
Gender  
[units: participants]
 
Female     4  
Male     16  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures

1.  Primary:   Change in Stride Length From Baseline   [ Time Frame: 1 hour ]

2.  Secondary:   Gait Velocity   [ Time Frame: 5 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Time to Walk 14 Meters   [ Time Frame: 5 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Fenna Phibbs M.D.
Organization: Vanderbilt University
phone: 615-936-2025
e-mail: fenna.phibbs@vanderbilt.edu


No publications provided


Responsible Party: Fenna Phibbs, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00993291     History of Changes
Other Study ID Numbers: 090873
Study First Received: October 8, 2009
Results First Received: August 22, 2011
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board