Status:
COMPLETED
One Pass thalamIc aNd subthalamIc stimulatiON
Lead Sponsor:
University Hospital Freiburg
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Parkinson's Disease
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
Main part of the study: Randomised, active controlled, double blinded (patient and observer blinded), monocentric trial with three treatments, three periods and six treatment sequences allocated acco...
Detailed Description
Tremor is the most salient symptom of Parkinson's disease (IPS=idiopathic Parkinson syndrome). Other symptoms are bradykinesia, rigidity and postural instability. As much as 75% of patients with IPS s...
Eligibility Criteria
Inclusion
- Male or female patients aged ≥ 35 and ≤ 75 years with a life expectancy of at least 5 years
- Patients with Parkinson's disease according to the criteria of the British Brain Bank as diagnosed by an in movement disorder specialized neurologist
- Parkinson patients are included with a medical treatment resistant and disabling resting and/or postural tremor as their major complaint and with a less prominent or absent hypokinetic-rigid component of their disease.
- Absence of postural instability (which would be aggravated under STN DBS)
- Hoehn \& Yahr stage 1-3. After stadium 3 patients will show increased incidence of falling that can be aggravated by (typical) STN DBS
- Disease duration for at least 2 years and routine DAT-scan shows clear indication for Parkinsonism and atypical Parkinson syndromes are ruled out by routine glucose (FDG) PET
- PDQ-39 to be completed within 42 days prior surgery
- Written informed consent
Exclusion
- Major Depression with suicidal thoughts
- Dementia (Mattis Dementia Rating Score ≤ 130)
- Patients with lifetime primary psychotic disorder, schizophrenia, or schizoaffective disorder
- Patients with acute psychosis as diagnosed by a psychiatrist
- Nursing care at home
- Unable to give written informed consent
- Surgical contraindications like deformed or displaced or not discernable target region, scarring after brain disease (infarction), need for continuous anticoagulation that cannot be bridged in order to obtain normal coagulation
- Patients with advanced stage cardiovascular disease
- Patients under immunosuppressive or chemotherapy because of malignant disease
- Patients who had previous intracranial surgery
- Patients who are already under DBS therapy
- Patients with aneurysm clips
- Patients with cochlear implants
- Simultaneous participation or previous participation within 30 days prior to start of screening in a clinical trial involving investigational medicinal product(s) or investigational medical device(s)
- Medications that are likely to cause interactions in the opinion of the investigator
- Known or persistent abuse of medication, drugs or alcohol
- Persons who are in a relationship of dependence/employment with the sponsor or the investigator
- Fertile women not using adequate contraceptive methods: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
- Current or planned pregnancy, nursing period
- Contraindications according to device instructions or Investigator's Brochure:
- Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy. The energy generated by diathermy can be transferred to the Vercise™ DBS System, causing tissue damage at the contact site resulting in severe patient injury or death.
- Magnetic Resonance Imaging (MRI): Patients implanted with the Vercise™ DBS System should not be subjected to MRI.
- Patient incapability: Patients who are unable to properly operate the Remote Control and Charging System should not be implanted with the Vercise™ DBS System.
- Poor surgical risks: The Vercise™ DBS System is not recommended for patients who - because of their primary disease or additional co-morbidities - are not likely to benefit from the DBS system implantation.
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02288468
Start Date
July 1 2015
End Date
November 18 2020
Last Update
July 21 2021
Active Locations (1)
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1
University of Freiburg - Medical Center - Dept. of Stereotactic and Functional Neurosurgery
Freiburg im Breisgau, Germany, 79110