Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: TOPS1 DBSDevice: TOPS2 DBSDevice: TOPS3 DBSDevice: Standard DBS
- Registration Number
- NCT04390867
- Lead Sponsor
- Deep Brain Innovations LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TOPS1 DBS TOPS3 DBS Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order. TOPS1 DBS TOPS1 DBS Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order. TOPS3 DBS Standard DBS Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order. TOPS1 DBS Standard DBS Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order. TOPS2 DBS TOPS2 DBS Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order. TOPS2 DBS Standard DBS Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order. TOPS3 DBS TOPS1 DBS Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order. Standard DBS TOPS2 DBS Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order. TOPS2 DBS TOPS3 DBS Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order. TOPS3 DBS TOPS3 DBS Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order. Standard DBS TOPS3 DBS Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order. Standard DBS Standard DBS Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order. TOPS1 DBS TOPS2 DBS Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order. TOPS2 DBS TOPS1 DBS Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order. TOPS3 DBS TOPS2 DBS Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order. Standard DBS TOPS1 DBS Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order.
- Primary Outcome Measures
Name Time Method Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS After 1 week treatment period using each pattern Average difference between the best TOPS and Standard. The MDS-UPDRS Part III is the sum of 33 scores evaluating a set of Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicates no symptom is present and a maximum score of 4 indicates the most severe symptom. The total scale range is 0-132, where higher scores indicate more severe symptoms.
Study related adverse device effects After 1 week treatment period using Standard Reported AEs
- Secondary Outcome Measures
Name Time Method Parkinson's Medication Use During 1 week treatment period using each pattern Parkinson's medication usage recorded in home use medication diary. Average difference between the best TOPS and Standard
Patient Global Impression of Improvement Rating After 1 week treatment period using each pattern Average difference in PGII between the best TOPS and Standard. Improvement is scored on a scale of 1 - 7 where 1 is Very Much Improved and 7 is Very Much Worse
Home Use "On Time" During 1 week treatment period using each pattern Home use Parkinson's disease motor symptom diary recording On Time without dyskinesia, On Time with non-troublesome dyskinesia, On Time with troublesome dyskinesia, Off Time, and Asleep Time. Average "On Time" difference between the best TOPS and Standard
Rest Tremor - Off medication/On DBS After 1 week treatment period using each pattern Measured using Kinesia One system. Average difference between the best TOPS and Standard
Type and severity of side effects of stimulation During 1 week treatment period using each pattern Proportion of participants experiencing side effects recorded in home use motor symptom diary and clinic. Average difference between the best TOPS and Standard
Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - On medication/On DBS After 1 week treatment period using each pattern Average difference between the best TOPS and Standard. The MDS-UPDRS Part III is the sum of 33 scores evaluating a set of Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicates no symptom is present and a maximum score of 4 indicates the most severe symptom. The total scale range is 0-132, where higher scores indicate more severe symptoms.
Postural Tremor - Off medication/On DBS After 1 week treatment period using each pattern Measured using Kinesia One system. Average difference between the best TOPS and Standard.
Bradykinesia - Off medication/On DBS After 1 week treatment period using each pattern Measured using Kinesia One system. Average difference between the best TOPS and Standard.
Clinical Global Impression of Improvement Rating After 1 week treatment period using each pattern Average difference in CGII score between the best TOPS and Standard. Improvement is scored on a scale of 1 - 7 where 1 is Very Much Improved and 7 is Very Much Worse
Test Pattern Use Count After 1 week treatment period using each pattern For each pattern, the number of subjects who go home with it and use it for the entire test period (\~7-14 days) will be counted to evaluate if any patterns are more or less likely to be skipped
Trial Locations
- Locations (3)
University of Florida
🇺🇸Gainesville, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Duke University
🇺🇸Durham, North Carolina, United States