This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01072656
First received: February 19, 2010
Last updated: May 1, 2017
Last verified: May 2017
Results First Received: July 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Chronic Pain
Intervention: Device: Deep Brain Stimulation for Thalamic Pain Syndrome

  Participant Flow
  Hide 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
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
  Hide 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
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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  40.0%      2  50.0%      4  44.4% 
Male      3  60.0%      2  50.0%      5  55.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1  20.0%      1  25.0%      2  22.2% 
Not Hispanic or Latino      4  80.0%      3  75.0%      7  77.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   5   4   9 


  Outcome Measures
  Show All 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:   Number of Participants Who Had 50% Improvement in PDI   [ Time Frame: 24 months post randomization follow up ]

3.  Secondary:   Number of Participants Who Would Undergo the Procedure Again.   [ Time Frame: End of Open Label Phase (24 months) ]

4.  Secondary:   Number of Patient Who Had >50% Reduction in VAS.   [ Time Frame: Baseline and 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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