Clinical trial NCT04390867: Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Official title: A Prospective, Randomized, Cross-Over Home-Use Study of TOPS® DBS for the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Lead sponsor: Deep Brain Innovations LLC
Sponsor class: INDUSTRY
First posted: 2020-05-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Random order of presentation of all three TOPS and Standard DBS in each participant
Primary purpose: TREATMENT

Brief summary: This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system. The purpose of this study is to determine if TOPS DBS can improve Parkinson's symptoms compared to Standard DBS.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosed with Parkinson's disease
* Implanted with unilateral or bilateral subthalamic DBS System to treat Parkinson's disease at least 6 months prior to the study date
* Responds to DBS by having demonstrated a minimum improvement in motor score

Key Exclusion Criteria:

* Score of \<24 on the Mini Mental Status Exam
* Abuses drugs or alcohol
* Pregnant
* History of significant cardiovascular, pulmonary, musculoskeletal, metabolic, or other neurological disorders (i.e. epilepsy, stroke)
* Prisoners, employees that report to investigators

Primary outcomes:
measure: Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS
timeFrame: After 1 week treatment period using each pattern
measure: Study related adverse device effects
timeFrame: After 1 week treatment period using TOPS1
measure: Study related adverse device effects
timeFrame: After 1 week treatment period using TOPS2
measure: Study related adverse device effects
timeFrame: After 1 week treatment period using TOPS3
measure: Study related adverse device effects
timeFrame: After 1 week treatment period using Standard
Secondary outcomes:
measure: Home Use "On Time"
timeFrame: During 1 week treatment period using each pattern
measure: Patient Global Impression of Improvement Rating
timeFrame: After 1 week treatment period using each pattern
measure: Parkinson's Medication Use
timeFrame: During 1 week treatment period using each pattern
measure: Rest Tremor - Off medication/On DBS
timeFrame: After 1 week treatment period using each pattern
measure: Postural Tremor - Off medication/On DBS
timeFrame: After 1 week treatment period using each pattern
measure: Bradykinesia - Off medication/On DBS
timeFrame: After 1 week treatment period using each pattern
measure: Type and severity of side effects of stimulation
timeFrame: During 1 week treatment period using each pattern
measure: Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - On medication/On DBS
timeFrame: After 1 week treatment period using each pattern
measure: Clinical Global Impression of Improvement Rating
timeFrame: After 1 week treatment period using each pattern
measure: Test Pattern Use Count
timeFrame: After 1 week treatment period using each pattern
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References: