Status:
COMPLETED
Integration of Auditory, and Deep Brain Stimulation to Enhance Deep Sleep in Parkinson's Disease
Lead Sponsor:
Christian Baumann
Collaborating Sponsors:
Klinik Lengg, Zurich
University Children's Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is an open-label trial to validate the local field potential (LFP) activity in the subthalamic nucleus (STN) for slow-wave detection during acoustic stimulation during nighttime sleep in Par...
Detailed Description
The objective of this study is to validate the STN signal for slow-wave detection during auditory stimulation. To test this, the electrophysiological activity within the STN will be measured as local ...
Eligibility Criteria
Inclusion
- Signed informed consent
- Diagnosis of PD along with international criteria with mild to moderate disease severity (Hoehn-Yahr (HY) stages ll-lll), selected for receiving STN-DBS therapy with the neurostimulator PERCEPT™
- Sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
- Age above 18 years
- Negative pregnancy test during screening in female patients of childbearing potential (except in women who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year)
Exclusion
- Failure to give informed consent
- Known presence of neurologic (other than PD), psychiatric, or systemic diseases (others than associated with PD)
- Clinical moderate to severe sleep-wake disorders (e.g. RLS-Index≥20, sleep apnea index ≥ 15 or, PLM-Index ≥ 15 if associated with arousals assessed during clinical PSG (in the framework of the pre-DBS work-up) and the clinical presentation of a RLS)
- Atypical or secondary Parkinsonism
- Severe medical conditions as renal insufficiency, liver failure, or congestive heart failure
- Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
- Regular use of benzodiazepines other long-acting central nervous system (CNS)-depressant substances or long-acting antidepressants
- Use of melatonin less than 1 day prior to recording session
- Substance or alcohol abuse (i.e. \> 0.5 l wine or 1 l beer per day)
- High caffeine consumption (\> 5 servings/day; including coffee, energy drink)
- Known or suspected drug- or medication abuse
- Hearing deficiency resulting in inability to hear the auditory stimuli during sleep (based on results of standard pure-tone threshold audiometry)
- Not tolerating AS during screening night
- Inability to follow the procedures of the study, e.g. due to language problems or cognitive deficits
- Participation in another study with the intervention within the 30 days preceding, and during the present study
- Previous enrolment in the current study
- Enrolment of the investigator, his/her family members, employees, and other dependent persons
- Shift work (work during the night)
- Travelling more than 2 time zones in the last month before the intervention starts or during the intervention (start of intervention will be adapted to fit with this criteria)
- Lack of safe contraception, defined as: Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female patients who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year are not considered as being of child bearing potential.
- During DBS implantation/ICU:
- Use of long-acting substances (i.e. long-lasting benzodiazepines, anti-depressants)
- Use of full anesthesia
- Atypical STN electrophysiology
- Miss-location of the DBS leads (location will be checked after surgery using SureTune™ Medtronic software based on CT and MRI)
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05184270
Start Date
November 10 2021
End Date
March 7 2023
Last Update
September 21 2023
Active Locations (1)
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1
Department of Neurology, University Hospital Zurich
Zurich, Switzerland, 8091