Back to resultsTemporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease (TOPS)
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TOPS1 DBS
TOPS2 DBS
TOPS3 DBS
Standard DBS
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Deep Brain Stimulation
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
Sites / Locations
- University of Florida
- Northwestern University
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
TOPS1 DBS
TOPS2 DBS
TOPS3 DBS
Standard DBS
Arm Description
Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order.
Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order.
Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order.
Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order.
Outcomes
Primary Outcome Measures
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.
Study related adverse device effects
Reported AEs
Study related adverse device effects
Reported AEs
Study related adverse device effects
Reported AEs
Study related adverse device effects
Reported AEs
Secondary Outcome Measures
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
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
Parkinson's Medication Use
Parkinson's medication usage recorded in home use medication diary. Average difference between the best TOPS and Standard
Rest Tremor - Off medication/On DBS
Measured using Kinesia One system. Average difference between the best TOPS and Standard
Postural Tremor - Off medication/On DBS
Measured using Kinesia One system. Average difference between the best TOPS and Standard.
Bradykinesia - Off medication/On DBS
Measured using Kinesia One system. Average difference between the best TOPS and Standard.
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
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04390867
Brief Title
Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Acronym
TOPS
Official Title
A Prospective, Randomized, Cross-Over Home-Use Study of TOPS® DBS for the Treatment of Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Business decision on June 2, 2022
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
February 2, 2022 (Actual)
Study Completion Date
February 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deep Brain Innovations LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Random order of presentation of all three TOPS and Standard DBS in each participant
Masking
ParticipantOutcomes Assessor
Masking Description
Participant and Outcomes Assessor blinded to DBS pattern in use
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TOPS1 DBS
Arm Type
Experimental
Arm Description
Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order.
Arm Title
TOPS2 DBS
Arm Type
Experimental
Arm Description
Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order.
Arm Title
TOPS3 DBS
Arm Type
Experimental
Arm Description
Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order.
Arm Title
Standard DBS
Arm Type
Active Comparator
Arm Description
Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order.
Intervention Type
Device
Intervention Name(s)
TOPS1 DBS
Intervention Description
TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
Intervention Type
Device
Intervention Name(s)
TOPS2 DBS
Intervention Description
TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
Intervention Type
Device
Intervention Name(s)
TOPS3 DBS
Intervention Description
TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
Intervention Type
Device
Intervention Name(s)
Standard DBS
Intervention Description
Standard is the pattern of stimulation that is usually delivered clinically by a DBS system
Primary Outcome Measure Information:
Title
Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS
Description
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.
Time Frame
After 1 week treatment period using each pattern
Title
Study related adverse device effects
Description
Reported AEs
Time Frame
After 1 week treatment period using TOPS1
Title
Study related adverse device effects
Description
Reported AEs
Time Frame
After 1 week treatment period using TOPS2
Title
Study related adverse device effects
Description
Reported AEs
Time Frame
After 1 week treatment period using TOPS3
Title
Study related adverse device effects
Description
Reported AEs
Time Frame
After 1 week treatment period using Standard
Secondary Outcome Measure Information:
Title
Home Use "On Time"
Description
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
Time Frame
During 1 week treatment period using each pattern
Title
Patient Global Impression of Improvement Rating
Description
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
Time Frame
After 1 week treatment period using each pattern
Title
Parkinson's Medication Use
Description
Parkinson's medication usage recorded in home use medication diary. Average difference between the best TOPS and Standard
Time Frame
During 1 week treatment period using each pattern
Title
Rest Tremor - Off medication/On DBS
Description
Measured using Kinesia One system. Average difference between the best TOPS and Standard
Time Frame
After 1 week treatment period using each pattern
Title
Postural Tremor - Off medication/On DBS
Description
Measured using Kinesia One system. Average difference between the best TOPS and Standard.
Time Frame
After 1 week treatment period using each pattern
Title
Bradykinesia - Off medication/On DBS
Description
Measured using Kinesia One system. Average difference between the best TOPS and Standard.
Time Frame
After 1 week treatment period using each pattern
Title
Type and severity of side effects of stimulation
Description
Proportion of participants experiencing side effects recorded in home use motor symptom diary and clinic. Average difference between the best TOPS and Standard
Time Frame
During 1 week treatment period using each pattern
Title
Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - On medication/On DBS
Description
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.
Time Frame
After 1 week treatment period using each pattern
Title
Clinical Global Impression of Improvement Rating
Description
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
Time Frame
After 1 week treatment period using each pattern
Title
Test Pattern Use Count
Description
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
Time Frame
After 1 week treatment period using each pattern
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
We'll reach out to this number within 24 hrs