High-frequency deep brain stimulation in the treatment of movement disorders
- Conditions
- Parkinson’s disease (PD) and essential tremor (ET)Nervous System DiseasesParkinson disease
- Registration Number
- ISRCTN13759640
- Lead Sponsor
- evro Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 3
To participate in the study, subjects must meet all of the following inclusion criteria:
1. Have been clinically diagnosed with either bilateral idiopathic Parkinson’s disease or unilateral or bilateral essential tremor, which has been refractory to conservative therapy for a minimum of 3 months and completed diagnostic work-up
2. Be 18 years of age or older at the time of enrollment
3. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
4. Be capable of subjective evaluation; patient must be able to describe and rate his/her disease state progression through the UPDRS
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements and procedures and attend all scheduled visits
7. Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator
To participate in this study, a subject must not meet any of the following exclusion criteria.
1. Have a medical condition, not intended to be treated with DBS that could interfere with study procedures, accurate UPDRS or FTD reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
2. Have a current diagnosis of a focal brain tumor in a relevant DBS target region or prominent generalized cortical atrophy, as determined by the investigator
3. Have a past medical history significant for seizures, as determined by the investigator
4. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator
5. Have a condition that would significantly increase perioperative risk including severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, symptomatic uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator
6. Any previous history of surgery of ipsilateral basal ganglia surgery (radio frequency or ultrasound lesion or prior DBS implant)
7. Any past medical history suggesting secondary or atypical parkinsonian symptoms including previous cerebrovascular accident, neurotoxin exposure, neuroleptic toxicity, tumor, encephalitis, abnormal iron deposits, or neurologic signs of cerebellar or upper motor neuron involvement or supranuclear gaze palsy
8. Be benefiting from an interventional procedure and/or surgery to treat their movement disorder (Subjects should be enrolled at least 30 days from last benefit)
9. Have an existing drug pump and/or another active implantable device such as a pacemaker
10. Have a condition currently requiring or likely to require the use of diathermy, Transcranial Magnetic Stimulation (TMS) or MRI imaging that is inconsistent with Senza II system guideline in the US manual
11. Have either a metastatic malignant neoplasm or untreated local malignant neoplasm
12. Have a life expectancy of less than one year
13. Have a local infection at the anticipated surgical entry site or an active systemic infection
14. Be pregnant or plan to become pregnant during the study. Women of childbearing potential who are sexually active must use a reliable form of birth control, or be surgically sterile, or be at least 2 years post-menopausal
15. Have a significant untreated addiction to dependency producing medications or have been a substance abuser (including opioids, benzodiazepines, alcohol and illicit drugs) within 6 months of enrollment
16. Have a metallic aneurysm clip that could interfere with device functioning
17. Have significant cognitive impairment or dementia that would interfere with study compliance or comprehension
18. Have untreated clinically significant depression as evidenced by a self-report score on the Beck Depression Inventory (BDI) II > 20. Patients presenting with depression may also be ruled out by clinical judgement of the investigator
19. Have evidence of acute psychosis or delirium as determined by the investigator
20. Be concomitantly participating in another clinical study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The feasibility of a future definitive trial is determined using:<br>1. The number of participants identified, approached, consented and completed, to inform the recruitment and timeline of a future fully-powered study<br>2. The acceptability and experience of the study process to participants and completion of outcome measures, to refine future study procedures<br>3. The performance of selected candidate primary outcome measures with respect to level of acceptability to participants (completion rates, perceived burden) and participant-perceived relevance and value, to determine the optimal primary outcome measure in a future study<br>4. Data completeness at follow up (participant attrition), standard deviation of the likely primary outcome measure, and the variability of the comparator condition, treatment as usual, across individuals and sites, to estimate sample size for a future study<br>Measured from enrolment until end of study (12 months follow up).
- Secondary Outcome Measures
Name Time Method Effectiveness and safety are assessed by the following:<br>1. Motor symptoms are measured using the Unified Parkinson’s Disease Rate Scale (UPDRS) at baseline, initial DBS lead implant, device activation, and 1, 2, 3, 6, and 12 month follow-up visits<br>2. Tremor is measured using the FTM (Fahn-Tolosa-Marin Tremor Rating Scale) at baseline, initial DBS lead implant, device activation, and 1, 2, 3, 6, and 12 month follow-up visits<br>3. Functioning is measured using the PDQ-39 (Parkinson’s Disease Questionnaire-39) at baseline, device activation, and 1, 2, 3, 6, and 12 month follow-up visits<br>4. Quality of Life in Essential Tremor is measured using the QUEST (Quality of Life in Essential Tremor) questionnaires at baseline, device activation, and 1, 2, 3, 6, and 12 month follow-up visits<br>5. Neurological status (motor, sensory and reflex functions) is measured using a neurological examination at every visit<br>6. Incidence of adverse events (AEs) is observed at every visit