Spinal Cord Stimulation for Painful Diabetic Neuropathy (DPN)

This study has been terminated.
(Insufficient Data Collected)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00487981
First received: June 15, 2007
Last updated: February 21, 2012
Last verified: February 2012
Results First Received: February 13, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetic Neuropathy
Pain
Peripheral Neuropathy
Intervention: Device: Precision Spinal Cord Stimulation

  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
Spinal Cord Stimulation (SCS) Group Spinal Cord Stimulation (SCS) Treatment Group

Participant Flow:   Overall Study
    Spinal Cord Stimulation (SCS) Group  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Hypothyroidism diagnosis                 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.
No text entered.

Reporting Groups
  Description
Spinal Cord Stimulation (SCS) Group Spinal Cord Stimulation (SCS) Treatment Group

Baseline Measures
    Spinal Cord Stimulation (SCS) Group  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  59  ± 0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   Pain Rating at 6 Months Post Activation Compared to Baseline   [ Time Frame: 6 months ]


  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
One subject enrolled.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lyn M. Pimentel, M.B.A.
Organization: Boston Scientific
phone: (661) 949-4174
e-mail: Lyn.Pimentel@bsci.com


No publications provided


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00487981     History of Changes
Other Study ID Numbers: SCS0206
Study First Received: June 15, 2007
Results First Received: February 13, 2012
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board