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Deep Brain Stimulation (DBS) for the Suppression of Tremor

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: 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
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE March 12, 2014
First Posted Date  ICMJE March 14, 2014
Last Update Posted Date March 2, 2015
Study Start Date  ICMJE October 2005
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2014)
Long term efficacy [ Time Frame: Yearly up to 5 years ]
Continued reduction of tremor scores yearly up to 5 years
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation (DBS) for the Suppression of Tremor
Official Title  ICMJE 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.
Brief Summary The purpose of the proposed study is to demonstrate the safety and efficacy of the Totally Implantable Deep Brain Stimulation System in the ventral intermediate (VIM) nucleus of the thalamus implanted for the treatment of tremor due to essential tremor. This study will be included in the Pre-Market Approval Application to support the safety of this device in use.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tremor
  • Action Tremor
  • Essential Tremor
  • Tremor, Limb
Intervention  ICMJE Device: Deep Brain Stimulation with the Libra System
Deep Brain Stimulation programmed to eliminate tremor
Study Arms  ICMJE Stimulation
Deep Brain Stimulation with the Libra System
Intervention: Device: Deep Brain Stimulation with the Libra System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 12, 2014)
128
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient or authorized representative has signed an informed consent.
  • Patient is over 18 years of age.
  • Patient is diagnosed with essential tremor for at least 3 years.
  • Patient has a disabling medical-refractory upper extremity tremor with no evidence of supraspinal central nervous system disease or injury (tremor not adequately controlled by medications for at least three (3) months before implant).
  • Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor.
  • Patient will maintain a constant dose of anti-tremor medication indicated as best medical management for one (1) month prior to enrollment in study.
  • Patient is available for appropriate follow-up times for the length of the study.

Exclusion Criteria:

  • Patient is not surgical candidate;
  • Patient has other clinically or medically significant disease;
  • Patient has any neurological injury or disease other than essential tremor;
  • Patient has any condition requiring repeated MRI scans;
  • Patient has any condition requiring diathermy;
  • Patients on anticoagulant medications;
  • Patient has untreated clinically significant depression;
  • Patient has had an electrical or electromagnetic implant (cochlear prosthesis, pacemaker etc);
  • Patient has had a prior thalamotomy or surgical ablation procedure in either side of the brain;
  • Patient has dementia interfering with their ability to co-operate or comply with study requirements or comprehend the informed consent (mini-mental exam score <24);
  • Patient abuses drugs or alcohol;
  • Patient has had botulinum toxin injections in the six (6) months prior to enrollment;
  • Patient has a history of cranial surgery;
  • Patient has a history of seizures;
  • Patient has any metallic implants that may interfere with the functioning of the device (e.g. aneurysm clips);
  • Patient has a history of stimulation intolerance in any area of the body;
  • Patient is a female of child bearing potential with a positive urine pregnancy test or not using adequate contraception.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02087046
Other Study ID Numbers  ICMJE C-04-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: DeLea Peichel Sponsor GmbH
PRS Account Abbott Medical Devices
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP