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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 127
- Locations
- 12
- Primary Endpoint
- Primary Safety Endpoint: Percentage of Participants With Device-related or Procedure Related Adverse Events
Study Overview
Brief Summary
The purpose of the proposed study is to demonstrate the safety and efficacy of the ANS Totally Implantable Deep Brain Stimulation System in the 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 DBS 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 postsurgery, 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 CRST, the QUEST, the 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.
Patients completed follow-up visits as part of the original protocol (C-04-02) for one year (or in some cases longer if patient was bilaterally implanted) and continued to complete additional visits as part of the Long-Term Follow-up protocol (C-06-03) for up to 5 years post implant.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Stimulation
ANS Totally Implantable Deep Brain Stimulation System
Intervention: ANS Totally Implantable Deep Brain Stimulation System (Device)
Outcomes
Primary Outcomes
Primary Safety Endpoint: Percentage of Participants With Device-related or Procedure Related Adverse Events
Time Frame: Within 180 days following the initial implant
Percentage of device-related or procedure related adverse events will be assessed within 6 months following the initial unilateral implant. All such adverse events will be counted for 180 days following surgery or until the day of the second implant, which ever comes first.
Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer
Time Frame: Day 180
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
Secondary Outcomes
- Global Assessment by Patient(Day 365)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician(Day 365)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Blind Reviewer(Day 180)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician(Day 365)
- Number of Participants Who Would Choose to Receive the DBS System Again(Day 365)
- Change From Baseline in Beck Depression Inventory II (BDI - II) Score for Depression Symptoms(Day 365)
- Change From Baseline in Mini Mental State Exam (MMSE) For Examination of Mental Status(Day 365)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Pouring Ability From Target Side Severity Scores, As Assessed by the Blind Reviewer(Day 180)
- Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician(Following 180 days of stimulation)
- Number of Participants Who Would Recommend the DBS System(Day 365)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician(Day 180)
- Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician(Day 365)
- SF36 Components and Individual Domains(Day 365)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician(Day 365)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician(Day 365)
- Quality of Life in Essential Tremor (QUEST): Overall Summary Index(Baseline)
- Global Assessment Scores by Examiner(Day 365)
- Mini Mental State Exam (MMSE) for Examination of Mental Status(Baseline)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician(Day 365)
- Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician(Following 180 days of stimulation)
- Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index(Day 365)
- Global Assessment by Caregiver(Day 365)
- Beck Depression Inventory II (BDI - II) Score for Depression Symptoms(Baseline)
- Subjective Assessment by Patient Since Activation of System(Day 365)
- Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms(Day 365)
- Global Assessment by Patient(Day 90)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician(Baseline)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician(Day 90)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician(Day 180)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician(Day 90)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician(Day 180)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician(Baseline)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician(Day 90)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician(Day 180)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician(Baseline)
- Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician(Day 90)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician(Baseline)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician(Day 90)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician(Day 180)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician(Baseline)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician(Day 90)
- Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician(Day 180)
- Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician(Baseline)
- Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician(Baseline)
- Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index(Day 90)
- Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index(Day 180)
- SF36 Components and Individual Domains(Baseline)
- SF36 Components and Individual Domains(Day 90)
- SF36 Components and Individual Domains(Day 180)
- Global Assessment Scores by Examiner(Baseline)
- Global Assessment by Patient(Baseline)
- Global Assessment Scores by Examiner(Day 90)
- Global Assessment Scores by Examiner(Day 180)
- Global Assessment by Caregiver(Baseline)
- Global Assessment by Caregiver(Day 90)
- Global Assessment by Caregiver(Day 180)
- Global Assessment by Patient(Day 180)
- Subjective Assessment by Patient Since Activation of System(Day 90)
- Subjective Assessment by Patient Since Activation of System(Day 180)
- Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms(Day 90)
- Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms(Day 180)
- Number of Participants Who Would Choose to Receive the DBS System Again(Day 90)
- Number of Participants Who Would Choose to Receive the DBS System Again(Day 180)
- Number of Participants Who Would Recommend the DBS System(Day 90)
- Number of Participants Who Would Recommend the DBS System(Day 180)