Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Nebraska
About this trial
Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream sleep) Sleep Behavior Disorder (RBD), Restless legs syndrome (RLS), periodic limb movement, excessive daytime sleepiness, and sleep apnea. Sleep is vital to homeostasis, cognition, and nervous system repair. The dysfunctional sleep accompanying PD adversely affects both motor and non-motor symptoms, resulting in diminished quality of life for both patients and caregivers, including impairments in mood and behavior, and increased morbidity and mortality. Knowledge of sleep phenomenology and pathology in humans has largely been informed by analysis of non-invasive scalp electroencephalogram (EEG), and despite the profound importance of sleep, the underlying neural circuits important for controlling sleep and wakefulness in humans remain poorly understood.
This study assesses whether adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Participants are adults with PD who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Prior to surgery, participant sleep patterns will be assessed with questionnaires and monitored with a non-invasive watch-like device. Approximately four months after implantation surgery, participants will each receive 2 1-week deep brain stimulation (DBS) treatments and 1 1-week control session with no DBS in random order. Sleep patterns will again be monitored during the treatments and compared to the patterns before surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Diagnosis of Idiopathic Parkinson's disease (PD) with motor symptoms present for a minimum of 4 years
Severe motor symptoms (e.g., motor fluctuations, dyskinesia, tremor, bradykinesia, rigidity) despite optimized medical therapy, that warrant surgical implantation of deep brain stimulation (DBS), according to standard clinical criteria
Unified Parkinson's Disease Rating Scale (UPDRS-III) score off medication 20 to 80, and improvement of at least 30% in UPDRS-III score on medications, or tremor-dominant PD (score >/= 2 on UPDRS-III tremor sub-score) or tremor in addition to other motor symptoms that are treatment-resistant and result in significant functional disability
Disqualifiers
Any medical condition considered to elevate risk for surgical complications, such as coagulopathy,, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia, or anticoagulant medications that cannot be safely discontinued for perioperative period
Pregnancy (women of child-bearing potential must have a negative urine pregnancy test prior to surgical procedures)
Significant untreated depression (Beck Depression Inventory-II, BDI-II > 20 or Geriatric Depression Scale, GDS, score > 8)
Personality or mood disorder symptoms that investigators believe will interfere with study requirements
Trial design
Design model
Crossover
Treatments tested in this trial
Deep Brain Stimulation
DeviceAll participants will undergo three 1-week interventions of stimulation during nighttime sleep over the course of three consecutive weeks of in-home sleep: adaptive stimulation, open-loop stimulation and no stimulation.
Treatment groups
20 Participants
are divided into 3 treatment groupsGroup A: Adaptive Deep Brain StimulationExperimental treatment 1 intervention
Group B: Open-loop Deep Brain StimulationActive comparator 1 intervention
Group C: No Deep Brain StimulationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Sleep Efficiency - Frequency
Sleep fragmentation frequency will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). Comparisons will be made between baseline and each of the interventions.
Time frame
Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)2
Sleep Efficiency - Duration
Sleep fragmentation duration will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). Comparisons will be made between baseline and each of the interventions.
Time frame
Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)3
Subjective Sleep Quality
Subjective sleep quality will be assessed using the Pittsburgh Sleep Diary. Comparisons will be made between baseline and each of the interventions.
Time frame
Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)Secondary outcomes
1
Duration of REM Sleep Stage
Change in the duration of rapid eye movement (REM or dream) stage sleep will be measured and compared between the 3 stimulation interventions. An artificial neural network, Dreem 3, will be used to identify sleep stage and duration.
Time frame
During intervention (approximately days 144 - 172)Sponsors and contacts
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University of Nebraska
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov