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Spinal Cord Stimulation for Painful Diabetic Neuropathy (DPN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00487981
Recruitment Status : Terminated (Insufficient Data Collected)
First Posted : June 19, 2007
Results First Posted : March 13, 2012
Last Update Posted : March 13, 2012
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetic Neuropathy
Peripheral Neuropathy
Intervention: Device: Precision Spinal Cord Stimulation

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

Participant Flow:   Overall Study
    Spinal Cord Stimulation (SCS) Group
Hypothyroidism diagnosis                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
Spinal Cord Stimulation (SCS) Group Spinal Cord Stimulation (SCS) Treatment Group

Baseline Measures
   Spinal Cord Stimulation (SCS) Group 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 59  (0) 
[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

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

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

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00487981     History of Changes
Other Study ID Numbers: SCS0206
First Submitted: June 15, 2007
First Posted: June 19, 2007
Results First Submitted: February 13, 2012
Results First Posted: March 13, 2012
Last Update Posted: March 13, 2012