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Trial record 29 of 1346 for:    "Seizure Disorder"

External Trigeminal Nerve Stimulation for Epilepsy

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ClinicalTrials.gov Identifier: NCT01159431
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : June 3, 2013
Last Update Posted : June 3, 2013
Sponsor:
Collaborators:
Epilepsy Foundation
Boston Scientific Corporation
Information provided by (Responsible Party):
Christopher DeGiorgio, Olive View-UCLA Education & Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Epilepsy
Seizure Disorders
Intervention Device: Trigeminal Nerve Stimulation
Enrollment 50
Recruitment Details Subjects were recruited beginning at Olive View/UCLA and Keck-USC between 3/2008 and 10/2010
Pre-assignment Details 6-week pretreatment baseline
Arm/Group Title Active Control
Hide Arm/Group Description Trigeminal Nerve Stimulation-High Settings Trigeminal Nerve Stimulation-Low Settings
Period Title: Overall Study
Started 25 25
Completed 23 19
Not Completed 2 6
Reason Not Completed
Adverse Event             1             2
non-compliance             1             1
Lack of Efficacy             0             3
Arm/Group Title Active Control Total
Hide Arm/Group Description Trigeminal Nerve Stimulation-High Settings Trigeminal Nerve Stimulation-Low Settings Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
33.1  (10.57) 34.2  (10.81) 33.44  (10.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
16
  64.0%
11
  44.0%
27
  54.0%
Male
9
  36.0%
14
  56.0%
23
  46.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title 50% Responder Rate
Hide Description

Change in responder rate, at end of study (18 weeks)

Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage.

Time Frame Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
Trigeminal Nerve Stimulation-High Settings
Trigeminal Nerve Stimulation-Low Settings
Overall Number of Participants Analyzed 23 19
Measure Type: Number
Unit of Measure: percentage of participants
40.5 15.6
2.Primary Outcome
Title Time to the 4th Seizure
Hide Description Number of Days to the 4th seizure
Time Frame treatment period (18-weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group-Baseline Control Group-Double Blind Period Treatment Group-Baseline Treatment Group-Double Blind Period
Hide Arm/Group Description:
Baseline
Sham Treatment
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 25 19 25 23
Mean (Standard Deviation)
Unit of Measure: days
23  (19) 18  (31) 12.5  (18) 15  (28)
3.Primary Outcome
Title Change in Seizure Frequency
Hide Description Percent change in seizure frequency from baseline
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
Trigeminal Nerve Stimulation-High Settings
Trigeminal Nerve Stimulation-Low Settings
Overall Number of Participants Analyzed 23 19
Median (Standard Deviation)
Unit of Measure: percentage change in seizures per month
-16.1  (15.4) -10.5  (11.1)
4.Secondary Outcome
Title Response Ratio: Mean Percent Change in Seizures
Hide Description Response Ratio: Mean Percent Change in seizures over the treatment period, where [T-B] / [T+B] x 100%, where T = seizure frequency during the treatment period, and B = seizure frequency during the baseline period.
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 23 19
Mean (Standard Deviation)
Unit of Measure: percentage change of RRATIO
-13.9  (6.7) -9.0  (6.8)
5.Secondary Outcome
Title Mood
Hide Description Mean change in score on the Beck Depression Inventory. The Beck Inventory is a patient reported mood scale. The minimum score is 0, and the maximum score is 63. Scores of less than 10 are considered in the normal range. Scores above 10 are consistent with depression. Higher scores indicate higher degrees of depression, with scores of > 25 consistent with severe depression.
Time Frame 18-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Control
Hide Arm/Group Description:
Trigeminal Nerve Stimulation-High Settings
Trigeminal Nerve Stimulation-Low Settings
Overall Number of Participants Analyzed 23 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.13  (1.35) -3.95  (1.22)
Time Frame 18-weeks
Adverse Event Reporting Description anxiety
 
Arm/Group Title Active Control
Hide Arm/Group Description Trigeminal Nerve Stimulation-High Settings Trigeminal Nerve Stimulation-Low Settings
All-Cause Mortality
Active Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      1/25 (4.00%)    
Nervous system disorders     
Seizure cluster  [1]  0/25 (0.00%)  0 1/24 (4.17%)  1
Indicates events were collected by systematic assessment
[1]
Seizure cluster requiring visit to the ER, not device related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Active Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/25 (20.00%)      4/25 (16.00%)    
Nervous system disorders     
headache   0/25 (0.00%)  0 1/25 (4.00%)  1
Psychiatric disorders     
Anxiety   1/25 (4.00%)  1 0/25 (0.00%)  0
Skin and subcutaneous tissue disorders     
skin irritation   4/25 (16.00%)  4 3/25 (12.00%)  3
Indicates events were collected by systematic assessment
Due to sample size and high variability in seizure frequency, median change did not achieve significance. To constrain variability, the RRATIO was used to assess seizure frequency. The RRATIO demonstrated within groups differences, p=0.04 ANOVA.
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: Dr. Christopher DeGiorgio
Organization: UCLA
Phone: 310-206-3753
Responsible Party: Christopher DeGiorgio, Olive View-UCLA Education & Research Institute
ClinicalTrials.gov Identifier: NCT01159431     History of Changes
Other Study ID Numbers: TNS-TDP-01
First Submitted: July 7, 2010
First Posted: July 9, 2010
Results First Submitted: February 1, 2013
Results First Posted: June 3, 2013
Last Update Posted: June 3, 2013