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

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ClinicalTrials.gov Identifier: NCT00993291
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : January 27, 2012
Last Update Posted : January 27, 2012
Sponsor:
Information provided by (Responsible Party):
Fenna Phibbs, Vanderbilt University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Procedure: Frequency change to 60 Hz
Procedure: Frequency change to 130 Hz

  Participant Flow

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

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.
No text entered.

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

Baseline Measures
   Baseline Frequency 
Overall Participants Analyzed 
[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.  

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: Fenna Phibbs, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00993291     History of Changes
Other Study ID Numbers: 090873
First Submitted: October 8, 2009
First Posted: October 12, 2009
Results First Submitted: August 22, 2011
Results First Posted: January 27, 2012
Last Update Posted: January 27, 2012