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RestoreSensor Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01106404
First received: April 2, 2010
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
Results First Received: January 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Pain
Intervention: Device: RestoreSensor Neurostimulation System

  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
The sponsor activated 10 study centers after the study protocol was approved by FDA in March 2010. The overall recruitment for study subjects lasted less than 5 months, with the first enrollment on April 20, 2010, and last enrollment on September 3, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Among the 79 subjects enrolled into the study, there were 3 subjects discontinued prior to implantation. The reasons for discontinuations were withdrawal of consent (n = 2) and eligibility criteria not met (n = 1). A total of 76 subjects were implanted and randomized at 4 weeks post implant.

Reporting Groups
  Description
6-week AdaptiveStim Followed by 6-week Manual Programming Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
6-week Manual Followed by 6-week AdaptiveStim Programming Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.

Participant Flow for 2 periods

 Period 1:   Period I (First 6 Weeks)
    6-week AdaptiveStim Followed by 6-week Manual Programming     6-week Manual Followed by 6-week AdaptiveStim Programming  
STARTED     36     40  
COMPLETED     33     38  
NOT COMPLETED     3     2  
Adverse Event                 2                 0  
Physician Decision                 1                 0  
Lost to Follow-up                 0                 1  
Lack of Efficacy                 0                 1  

Period 2:   Period II (Second 6 Weeks)
    6-week AdaptiveStim Followed by 6-week Manual Programming     6-week Manual Followed by 6-week AdaptiveStim Programming  
STARTED     33     38  
COMPLETED     33     38  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
6-week AdaptiveStim Followed by 6-week Manual Programming Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
6-week Manual Followed by 6-week AdaptiveStim Programming Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
Total Total of all reporting groups

Baseline Measures
    6-week AdaptiveStim Followed by 6-week Manual Programming     6-week Manual Followed by 6-week AdaptiveStim Programming     Total  
Number of Participants  
[units: participants]
 		  36     40     76  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     31     30     61  
>=65 years     5     10     15  
Age  
[units: years]
Mean ± Standard Deviation 		  52.5  ± 13.0     53.1  ± 14.1     52.8  ± 13.5  
Gender  
[units: participants]
 		     
Female     18     27     45  
Male     18     13     31  
Region of Enrollment  
[units: participants]
 		     
United States     36     40     76  
average Numeric Pain Rating Scale (NPRS) [1]
[units: units on a scale]
Mean ± Standard Deviation 		  6.26  ± 1.48     5.88  ± 2.15     6.06  ± 1.86  
worst Numeric Pain Rating Scale (NPRS) [2]
[units: units on a scale]
Mean ± Standard Deviation 		  7.60  ± 1.15     7.60  ± 1.63     7.60  ± 1.41  
[1] NPRS is a 11-point scale with numbers from 0 to 10, with 0 meaning “No pain” and 10 meaning “Pain as bad as you can imagine.” For average NPRS, study subjects were instructed to “Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours.”
[2] NPRS is a 11-point scale with numbers from 0 to 10, with 0 meaning “No pain” and 10 meaning “Pain as bad as you can imagine.” For worst NRPS, study subjects were instructed to “Please rate your pain by indicating the number that best describes your worst pain in the last 24 hours.”



  Outcome Measures
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1.  Primary:   Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm   [ Time Frame: 16 weeks post-implant ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming   [ Time Frame: 16 weeks post-implant ]
  Show Outcome Measure 2

3.  Secondary:   Manual Adjustments Presented as Button Presses   [ Time Frame: Baseline, 10 weeks and 16 weeks post-implant ]
  Show Outcome Measure 3

4.  Secondary:   NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant   [ Time Frame: Baseline, 10 weeks and 16 weeks post-implant ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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 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 less than or equal to 60 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.


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.  


Results Point of Contact:  
Name/Title: Mark Sun, Senior Clinical Research Manager
Organization: Neuromodulation Emerging Therapy Clinical Research, Medtronic, Inc
phone: 763-526-8098
e-mail: mark.sun@medtronic.com


No publications provided by MedtronicNeuro

Publications automatically indexed to this study:


Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01106404     History of Changes
Other Study ID Numbers: 1651
Study First Received: April 2, 2010
Results First Received: January 12, 2012
Last Updated: August 17, 2012
Health Authority: United States: Food and Drug Administration