Sensing in Sleep Deep Brain Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
Participants in this study have Parkinson's Disease and already have a device, called the Percept RC Deep Brain Stimulation device implanted. People with Parkinson's disease often have issues related to sleep such as bad quality of sleep, waking up often and sleep apnea (breathing stops and starts during sleep).
For this study, participants will be sleeping overnight in the study sleep lab for two nights. One night, Deep Brain Stimulation (DBS) device turned on and one night with the DBS off, either in this order or the reverse.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability of subject to understand and the willingness to sign a written informed consent document.
Males and females; Age 40-80
Subjects with the diagnosis of idiopathic PD consistent with the United Kingdom Parkinson Disease society brain bank criteria, or documented diagnosis of Parkinson Disease who have a Deep Brain Implant, Percept RC device to subthalamic nucleus (STN) or Globus pallidus internus (GPi).
Willingness to adhere to the PSG regimen and turn DBS off for one night.
Disqualifiers
History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA).
History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy.
History of Dementia.
Report dopaminergic medication changes in the past month.
Trial design
Design model
Crossover
Treatments tested in this trial
Polysomnography ON stimulation then OFF
DevicePatients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "ON" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.
Polysomnography OFF stimulation then ON
DevicePatients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "OFF" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: STN-DBS GroupExperimental treatment 2 interventions
Group B: GPi-DBS GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Sensing & Sleep: Parkinson's Disease Sleep Assessment
A 7 item to rate sleep experience scored 0=unsure, 1=No and 2=Yes. Total range of scores is from 0-14 with a higher score indicating more issues with sleep
Time frame
Day 1 to Day 142
Motor severity
Motor severity will be assessed by the Movement Disorders Society - Unified Parkinson's Disease Rating Scale - part III. This scale is the gold standard for measuring the severity and progression of PD. Part III entails motor examination which consists of 18 questions that are scored on a 0-4 scale. Higher scores suggest greater severity and progressing disease.
Time frame
Baseline to Day 143
Epworth Sleepiness Scale (ESS)
The ESS is a short, self-administered survey that asks respondents to rate their likelihood of dozing off in eight different situations on a scale of 0-3. The total score ranges from 0-24, and is used to estimate if the respondent has excessive daytime sleepiness that may require medical attention. A score over 10 is abnormal. Higher scores suggest greater severity of daytime sleepiness.
Time frame
Baseline to Day 14Sponsors and contacts
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Source ClinicalTrials.gov