Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Cross-Over Home-Use Study of TOPS® DBS for the Treatment of Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: TOPS1 DBS
* Device: TOPS2 DBS
* Device: TOPS3 DBS
* Device: Standard DBS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Random order of presentation of all three TOPS and Standard DBS in each participant
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOPS1 DBS<br>Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order. | Device: TOPS1 DBS<br>* TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: TOPS2 DBS<br>* TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: TOPS3 DBS<br>* TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: Standard DBS<br>* Standard is the pattern of stimulation that is usually delivered clinically by a DBS system<br>|
| Experimental: TOPS2 DBS<br>Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order. | Device: TOPS1 DBS<br>* TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: TOPS2 DBS<br>* TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: TOPS3 DBS<br>* TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: Standard DBS<br>* Standard is the pattern of stimulation that is usually delivered clinically by a DBS system<br>|
| Experimental: TOPS3 DBS<br>Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order. | Device: TOPS1 DBS<br>* TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: TOPS2 DBS<br>* TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: TOPS3 DBS<br>* TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: Standard DBS<br>* Standard is the pattern of stimulation that is usually delivered clinically by a DBS system<br>|
| Active Comparator: Standard DBS<br>Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order. | Device: TOPS1 DBS<br>* TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: TOPS2 DBS<br>* TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: TOPS3 DBS<br>* TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system<br>Device: Standard DBS<br>* Standard is the pattern of stimulation that is usually delivered clinically by a DBS system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS | 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. | After 1 week treatment period using each pattern | 
| Study related adverse device effects | Reported AEs | After 1 week treatment period using TOPS1 | 
| Study related adverse device effects | Reported AEs | After 1 week treatment period using TOPS2 | 
| Study related adverse device effects | Reported AEs | After 1 week treatment period using TOPS3 | 
| Study related adverse device effects | Reported AEs | After 1 week treatment period using Standard | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home Use On Time | 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 | During 1 week treatment period using each pattern | 
| Patient Global Impression of Improvement Rating | 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 | After 1 week treatment period using each pattern | 
| Parkinson's Medication Use | Parkinson's medication usage recorded in home use medication diary. Average difference between the best TOPS and Standard | During 1 week treatment period using each pattern | 
| Rest Tremor - Off medication/On DBS | Measured using Kinesia One system. Average difference between the best TOPS and Standard | After 1 week treatment period using each pattern | 
| Postural Tremor - Off medication/On DBS | Measured using Kinesia One system. Average difference between the best TOPS and Standard. | After 1 week treatment period using each pattern | 
| Bradykinesia - Off medication/On DBS | Measured using Kinesia One system. Average difference between the best TOPS and Standard. | After 1 week treatment period using each pattern | 
| Type and severity of side effects of stimulation | Proportion of participants experiencing side effects recorded in home use motor symptom diary and clinic. Average difference between the best TOPS and Standard | During 1 week treatment period using each pattern | 
| Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - On medication/On DBS | 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. | After 1 week treatment period using each pattern | 
| Clinical Global Impression of Improvement Rating | 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 | After 1 week treatment period using each pattern | 
| Test Pattern Use Count | 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 | After 1 week treatment period using each pattern | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation