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Deep Brain Stimulation in Patients With Dystonia (STN DBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00773604
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dystonia
Intervention Device: Medtronic implantable deep brain stimulation (DBS) system
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label Cohort
Hide Arm/Group Description This was a single arm open label study of 9 patients who were treated with STN DBS for isolated dystonia
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Open Label Cohort
Hide Arm/Group Description This was a single arm open label study of 9 patients who were treated with STN DBS for isolated dystonia
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
48.95
(17 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
1.Primary Outcome
Title The Toronto Western Spasmodic Rating Scale (TWSTRS) Movement Scores Measured Before DBS Surgery (Baseline) and at 12 Months
Hide Description Total TWSTRS score range is 0-88, where higher score indicates worse symptoms. Values are calculated by baseline minus 12 month, where higher difference score of change between baseline and 12 months means better outcome (more improvement)
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients implanted and treated with DBS
Arm/Group Title Open Label Cohort
Hide Arm/Group Description:
This was a single arm open label study of 9 patients who were treated with STN DBS for isolated dystonia
Overall Number of Participants Analyzed 9
Mean (Full Range)
Unit of Measure: TWSTRS total score change
33.5
(9.2 to 57.75)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description DBS treatment patients
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%)
Total   9/9 (100.00%) 
Blood and lymphatic system disorders   
Blood pressure instability   1/9 (11.11%) 
Ear and labyrinth disorders   
Humming sounds in ear, worsened *  1/9 (11.11%) 
General disorders   
Handwriting difficulties *  1/9 (11.11%) 
Metabolism and nutrition disorders   
Weight gain *  4/9 (44.44%) 
Musculoskeletal and connective tissue disorders   
Knee dislocation *  1/9 (11.11%) 
Knee injury *  1/9 (11.11%) 
Hip pain, worsened *  1/9 (11.11%) 
Nervous system disorders   
Dyskinesia   8/9 (88.89%) 
Dysarthria   2/9 (22.22%) 
Dysphasia   2/9 (22.22%) 
Shock-like sensations *  1/9 (11.11%) 
Migraine headaches, worsened *  1/9 (11.11%) 
Sensory deficit in hand, worsened   1/9 (11.11%) 
Lower extremity paresthesias   1/9 (11.11%) 
Fall *  1/9 (11.11%) 
Fourth cranial nerve palsy, preexisting *  1/9 (11.11%) 
Psychiatric disorders   
Depression, transient worsening   5/9 (55.56%) 
Anxiety, worsened   2/9 (22.22%) 
Confusion   1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Transient erythema around parietal incision site *  1/9 (11.11%) 
Surgical and medical procedures   
Subgaleal cerebral fluid collection around burr-hole cap *  1/9 (11.11%) 
Persistent pain at IPG site *  1/9 (11.11%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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: Jill Ostrem
Organization: University of California, San Francisco
Phone: 415-353-7885
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00773604     History of Changes
Other Study ID Numbers: Private donor
First Submitted: October 7, 2008
First Posted: October 16, 2008
Results First Submitted: December 18, 2018
Results First Posted: February 19, 2019
Last Update Posted: February 19, 2019