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Safety Study of Deep Brain Stimulation to Manage Thalamic Pain Syndrome (DBS)

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Andre Machado, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
NCT01072656
First received: February 19, 2010
Last updated: July 20, 2016
Last verified: July 2016
Results First Received: July 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Chronic Pain
Intervention: Device: Deep Brain Stimulation for Thalamic Pain Syndrome

  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
11 participants signed informed consent, 10 participants had surgery, 1 participant dropped the study prior to randomization phase, 9 participants were analyzed.

Reporting Groups
  Description
Active First active stimulation programmed to the settings found to be optimal during the titration phase
Sham First sham stimulation - IPG ON, at 0 Volt

Participant Flow for 2 periods

Period 1:   First Intervention
    Active First   Sham First
STARTED   5   4 
COMPLETED   5   4 
NOT COMPLETED   0   0 

Period 2:   Second Intervention
    Active First   Sham First
STARTED   5   4 
COMPLETED   5   4 
NOT COMPLETED   0   0 



  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
Active First active stimulation programmed to the settings found to be optimal during the titration phase
Sham First sham stimulation - IPG ON, at 0 Volt
Total Total of all reporting groups

Baseline Measures
   Active First   Sham First   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   4   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 51  (5.9)   54  (5.3)   52  (5.5) 
Gender 
[Units: Participants]
     
Female   2   2   4 
Male   3   2   5 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   1   2 
Not Hispanic or Latino   4   3   7 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   5   4   9 


  Outcome Measures

1.  Primary:   Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)   [ Time Frame: Blinded stimulation phase (3 Months) ]

2.  Secondary:   A 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index) at the End of the Open Label Phase Compared to the Pre-implantation Baseline   [ Time Frame: 24 months post randomization follow up ]
Results not yet reported.   Anticipated Reporting Date:   03/2017   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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Andre Machado
Organization: Cleveland Clinic
phone: 216-444-4270
e-mail: machada@ccf.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andre Machado, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT01072656     History of Changes
Other Study ID Numbers: AGM-001
1DP2OD006469-01 ( US NIH Grant/Contract Award Number )
Study First Received: February 19, 2010
Results First Received: July 20, 2016
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration