Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients (NCT04976569) | Clinical Trial Compass
UnknownNot Applicable
Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients
China5 participantsStarted 2021-08-10
Plain-language summary
Sleep disorder is one of the most burdensome non-motor symptoms in Parkinsonian patients. Typical manifestations include RBD, decreased sleep efficiency, decreased slow wave sleep, daytime sleepiness, increased sleep latency and wakefulness during sleep. Subthalamic nucleus (STN) deep brain stimulation (DBS) has been reported to improve sleep dysfunction in several studies, mostly due to its improvement in motor dysfunction. However, there are limited research about specific STN-DBS stimulation pattern for sleep architecture regulation, and whether suboptimal parameter combinations for motor has potential benefits for sleep improvement has not been studied. Here we use different parameter combination in STN-DBS, especially by changing stimulation contact and frequency, to explore the specific stimulation pattern for normalizing sleep architecture and increasing slow wave sleep.
Who can participate
Age range50 Years ā 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Diagnosis of Parkinson's disease: The diagnostic criteria for Parkinson's disease are the Clinical Diagnostic Criteria of UK PD Society Brain Bank Clinical Diagnostic Criteria or 2015 MDS Clinical Diagnostic Criteria for PD.All diagnoses of Parkinson's disease were made by three neurologists who were experienced in the field of movement disorders.
ā. Bilateral STN-DBS has been implanted for more than 1 year, and stable drug therapy regimen and parameter program control regimen have been maintained for 6 weeks or more;
ā. Patients with onset age of 50 years and above;
ā. Do not use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night.
Exclusion criteria
ā. Patients who underwent pallidotomy and other brain surgery;
ā. Other patients with secondary Parkinson's syndrome and Parkinsonism-plus syndrome;
ā. Patients with other central nervous system and peripheral nervous system diseases;
ā. Patients complicated with severe medical system diseases, patients with unstable vital signs and unable to tolerate clinical evaluation;
What they're measuring
1
ratio of slow wave sleep
Timeframe: through study completion, an average of 1 year
2
ratio of rem sleep
Timeframe: through study completion, an average of 1 year
3
Sleep Efficiency
Timeframe: through study completion, an average of 1 year