Status:
COMPLETED
Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders
Lead Sponsor:
KU Leuven
Conditions:
Parkinson Disease
Essential Tremor
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Parkinson's disease and essential tremor are chronic movement disorders for which there is no cure. When medication is no longer effective, deep brain stimulation (DBS) is recommended. Standard DBS is...
Detailed Description
The study had three stages. In the first stage, a wide range of investigatory pulse shapes in a small number of patients. The effect of the pulses on the therapeutic window will be assessed. Stage 2 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for PD:
- Diagnosis of idiopathic Parkinson's disease where the diagnosis was made by a Movement Disorder Specialist according to the MDS criteria of 2015, with a Hoehn and Yahr scale (H\&Y) of at least 2 (bilateral involvement).
- Onset of the symptoms more than five years ago.
- MDS-UPDRS-III score of ≥30 without medication or DBS.
- Electrodes are implanted in target area STN.
- Inclusion Criteria for ET:
- Patient is diagnosed with essential tremor by a Movement Disorder Specialist.
- Diagnosis since more than 3 years.
- Patient has a disabling medical-refractory upper extremity tremor without medication or DBS.
- 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 without medication or DBS.
- Electrodes are implanted in target area VIM.
- General
- Post-op the implanted electrodes pass an integrity check, i.e. no open or shorted electrodes.
- Stable medications
- Lack of dementia or depression.
- Patient is willing and able to comply with all visits and study related procedures
- Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Patient can tolerate at least 12 hours OFF medication and per clinical judgement be able to perform all study related procedures
Exclusion
- Any significant psychiatric problems, including unrelated clinically significant depression.
- Any current drug or alcohol abuse.
- Any history of recurrent or unprovoked seizures.
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months.
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04725045
Start Date
February 12 2019
End Date
April 14 2022
Last Update
April 29 2022
Active Locations (1)
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1
KU Leuven
Leuven, Belgium, 3000