Deep Brain Stimulation (DBS) for the Suppression of Tremor
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|ClinicalTrials.gov Identifier: NCT02087046|
Recruitment Status : Unknown
Verified February 2015 by Abbott Medical Devices.
Recruitment status was: Active, not recruiting
First Posted : March 14, 2014
Last Update Posted : March 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Tremor Action Tremor Essential Tremor Tremor, Limb||Device: Deep Brain Stimulation with the Libra System||Not Applicable|
This study is designed as a prospective, multi-centered study for 365 days in duration from device implantation. A maximum of 12 sites will enroll 160 patients.
Each patient will be screened and then undergo a baseline evaluation followed by unilateral or bilateral implantation of the Deep Brain Stimulation system.
During the implantation procedure, each patient will undergo a trial of stimulation in the operating room. The device may be internalized after a successful intra-operative trial or at a later surgery (no later than 4 weeks after initial lead placement). If the device is not activated immediately post-surgery, the patient may return to the clinic to determine optimum stimulation programming. Device programming will be optimized in as many visits as necessary following implantation. The day that the device is fully implanted will be classified as "Day 0" for each patient.
After "Day 0" the patient will return to clinic for evaluations at, Day 90 (+ 14 days), and Day 180 (+ 14 days) and Day 365 (approximately 12 months + 30 days after Day 0). These evaluations consist of the Clinical Rating Scale for Tremor (CRST), the Quality of Life in Essential Tremor (QUEST), the Short Form questionnaire (SF36), Patient and caregiver Global Ratings and the Patient Satisfaction Rating.
At Baseline and Day 180, the CRST evaluation session will be video recorded for analysis by an independent evaluator unaware of the functioning of the device. Additionally, at the Day 180 visit, the physician will have the option to provide the patient with amplitude control. A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.
After the 1 year study patient may be enrolled in another protocol (C-06-03) for an additional 4 years. This observational, long term follow up study will continue to monitor the safety and efficacy of the Libra Deep Brain Stimulation System.
If necessary, after the C-06-03 protocol the patients will have continued access to the investigational device through a compassionate use protocol (C-13-02).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Clinical Evaluation of the Advanced Neuromodulation System (ANS) Totally Implantable Deep Brain Stimulation System for the Suppression of Tremor in the Upper Extremities of Patients With Essential Tremor.|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||December 2017|
Deep Brain Stimulation with the Libra System
Device: Deep Brain Stimulation with the Libra System
Deep Brain Stimulation programmed to eliminate tremor
- Efficacy [ Time Frame: 180 days ]Reduction in the blinded evaluation of postural or kinetic tremor of the target limb in essential tremor patients on medication with stimulation On versus stimulation Off at 180 days.
- Long term efficacy [ Time Frame: 6 months and 1 year ]Reduction in postural or kinetic tremor of the non-target limb in essential tremor patients who received a bilateral implant in the "ON" medication state with stimulation "ON" versus stimulation "OFF" at 6 months and one year.
- Safety [ Time Frame: 1 -year ]Incidence of adverse events that occur over the study duration and malfunctions of study device
- Quality of Life [ Time Frame: 1 year ]Improvement in the quality of life measure as determined by the Short Form questionnaire (SF-36) and the Quality of Life in Essential Tremor (QUEST) questionnaire
- Global ratings [ Time Frame: 6 months and 1 year ]Improvement of patient and caregiver Global Ratings
- Patient Satisfaction [ Time Frame: 6 months and 12 months ]Rate of patient satisfaction
- Long term efficacy [ Time Frame: Yearly up to 5 years ]Continued reduction of tremor scores yearly up to 5 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087046
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|Loma Linda University School of Medicine|
|Loma Linda, California, United States, 92354|
|Pacific Hills Neurosurgery Medical Group|
|Pasadena, California, United States, 91105|
|University of San Francisco|
|San Francisco, California, United States, 94122|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Jacksonville, Florida, United States, 32224|
|United States, Michigan|
|Dearborn, Michigan, United States, 48124|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|University of Rochester|
|Rochester, New York, United States, 14618|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37212|
|United States, Texas|
|Neurology Specialists of Dallas|
|Dallas, Texas, United States, 75231|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Study Director:||DeLea Peichel||Sponsor GmbH|