This is a prospective, multi-center, single arm post-market clinical follow-up study. The present study investigates a product authorized on the European market that will be used per its intended use, and all procedures involved follow the standard of care. This is an observational study to provide clinical evidence in support of DBS effectiveness in the treatment of ET when delivered by the directSTIM DBS system. Twenty-one patients will be enrolled in this study. Subjects selected to participate in the study will be ET patients referred to uni- or bilateral DBS implant who meet the inclusion criteria and none of the exclusion criteria. Primary effectiveness variables will be measured at baseline for the identification of the worst limb (most affected by the disease), then 3 months post-surgery. Safety events will be collected between implant and 3-month visit, to evaluate potential confounding factors. After completing the 3-month visit, subjects will exit the study, and continue to be followed by their physician per usual care. Study will be conducted at minimum 3 centers in Europe.
This study investigates the benefits and safety of the use of the directSTIM Deep Brain Stimulation (DBS) system within its intended use, to deliver DBS therapy to patients suffering from Essential Tremor (ET) whose motor symptoms are no longer optimally controlled through pharmaceutical treatment. The objective of this study is to show that directSTIM is not inferior to competitor DBS Systems at alleviating postural or kinetic symptoms of Essential Tremor through the delivery of Deep Brain Stimulation therapy. Data to be analyzed will be collected from ET patients referred for DBS surgery, who chose to get the directSTIM DBS System implanted after discussing its risks and benefits with their clinician. All procedures involving the patient and the device follow the standard of care in place at the site for DBS.
Study Type
OBSERVATIONAL
Enrollment
21
implant and DBS therapy with the directSTIM™ DBS system
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Hamburg
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Münster
Münster, Germany
Change in the motor performance subscale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) score of target limb
The motor scale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) measures the maximum tremor severity in various body regions in different positions (rest, postural, kinetic). Each body area is evaluated in Part A of the FTM ETRS, which is composed of 10 questions. The FTM ETRS 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. The target limb (arm) will be identified at baseline for each patient as the limb most severely affected by tremors (highest score in postural or kinetic assessment in part A). The primary efficacy outcome is the mean percentage difference, 3 months post-implant, between the with and without stimulation states, as measured on the target limb identified at baseline, by the individual performance subscale score (i.e. postural or kinetic) on the FTM ETRS.
Time frame: 3 months
Proportions of Adverse Events and Device Deficiencies observed
Proportions of the following events from DBS implant through study completion: * Adverse Events: * Surgery-related * Device-related * Therapy-related * Device deficiencies
Time frame: 3 months
Change in total motor score on the Fahn Tolosa Marin Essential Tremor Rating Scale
The motor scale of the Fahn Tolosa Marin Essential Tremor Rating Scale (FTM ETRS) measures the maximum tremor severity in various body regions in different positions (rest, postural, kinetic). FTM ETRS is divided into 3 parts (A, B and C). The total motor score is calculated by summation of the individual scores to questions 1-15 of parts A and B. Maximum score of Part A is 88 points while that of Part B is of 36 points. The secondary efficacy OBJECTIVE is the mean difference between the with and without stimulation states, 3 months post-implant, as measured by the total motor score on the FTM ETRS. A high total motor score (i.e. close to 124) indicates overall poor motor performance - i.e. severe tremor. High difference value between total motor score measured with and without stimulation indicates a strong improvement.
Time frame: 3 months
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