Brain Stimulation for the Treatment of Tourette Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01329198
First received: March 25, 2011
Last updated: September 11, 2014
Last verified: September 2014
Results First Received: April 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tourette Syndrome
Intervention: Device: NeuroPace RNS® (responsive neurostimulation) System Deep Brain Stimulator

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sham DBS

Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.

NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.

  • One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
  • By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
  • Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days.
Active DBS

Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects

NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.

  • One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
  • By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
  • Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days.

Participant Flow:   Overall Study
    Sham DBS     Active DBS  
STARTED     3     2  
COMPLETED     3     2  
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
Sham DBS

Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.

NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.

  • One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
  • By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
  • Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days.
Active DBS

Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects

NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.

  • One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.
  • By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.
  • Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days.
Total Total of all reporting groups

Baseline Measures
    Sham DBS     Active DBS     Total  
Number of Participants  
[units: participants]
  3     2     5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     2     5  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     1     3  
Male     1     1     2  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     3     2     5  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     3     2     5  



  Outcome Measures
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1.  Primary:   Mean Change in Yale Global Tic Severity Scale (YGTSS) Scores From Baseline to 6 Months Across All Study Participants Presented   [ Time Frame: Baseline to 6 Months ]

2.  Secondary:   Correlation of Tics and Neural Physiology   [ Time Frame: Baseline to 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
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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 NOT 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.


Results Point of Contact:  
Name/Title: Assistant Director of Clinical Trials
Organization: University of Florida Center for Movement Disorders & Neurorestoration
phone: 352-294-5000
e-mail: stacy.merritt@neurology.ufl.edu


No publications provided by University of Florida

Publications automatically indexed to this study:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01329198     History of Changes
Other Study ID Numbers: 00068500
Study First Received: March 25, 2011
Results First Received: April 8, 2014
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration