Sleep-specific DBS Therapy in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Minnesota
About this trial
Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the U.S and worldwide. The brain mechanisms underlying these sleep disorders, and the effects of therapeutic interventions such as deep brain stimulation on sleep-related neuronal activity and sleep behavior, are not well understood. Results from this study will provide a better understanding of the brain circuitry involved in disordered sleep in PD and inform the development of targeted therapeutic interventions to treat sleep disorders in people with neurodegenerative disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of idiopathic PD
At least 21 years old
Existing or planned 7T brain imaging
Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care
Disqualifiers
Other significant neurological disorder
History of dementia
Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
Pregnant women
Trial design
Design model
Single group
Treatments tested in this trial
Clinically optimized deep brain stimulation
Other interventionParticipants will have DBS implanted as standard-of-care. We will be examining the effects of their regular clinical stimulation settings versus no stimulation.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: OFF DBS followed by ON DBSExperimental treatment 1 intervention
Group B: ON DBS followed by OFF DBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
pallidopeduncular and pedunculopallidal pathway activation
Percent of pallidopeduncular and pedunculopallidal pathway activation
Time frame
6 months post DBS surgery2
pallidopeduncular and pedunculopallidal pathway activation
Percent of pallidopeduncular and pedunculopallidal pathway activation
Time frame
12 months post DBS surgery3
GPe activation
percent of GPe activation
Time frame
6 months post DBS surgery4
GPe activation
percent of GPe activation
Time frame
12 months post DBS surgerySponsors and contacts
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Source ClinicalTrials.gov