Parkinson Disease
Conditions
Keywords
Deep Brain Stimulation
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.
Interventions
DEVICETOPS1 DBS
TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
DEVICETOPS2 DBS
TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
DEVICETOPS3 DBS
TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
DEVICEStandard DBS
Standard is the pattern of stimulation that is usually delivered clinically by a DBS system
Sponsors
Deep Brain Innovations LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participant and Outcomes Assessor blinded to DBS pattern in use
Intervention model description
Random order of presentation of all three TOPS and Standard DBS in each participant
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 TOPS1 | Reported AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed