Study Stopped
Business decision on June 2, 2022
Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
TOPS
A Prospective, Randomized, Cross-Over Home-Use Study of TOPS® DBS for the Treatment of Parkinson's Disease
1 other identifier
interventional
6
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Jul 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedStudy Start
First participant enrolled
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2022
CompletedJune 27, 2022
September 1, 2021
1.5 years
May 4, 2020
June 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (10)
Home Use "On Time"
During 1 week treatment period using each pattern
Patient Global Impression of Improvement Rating
After 1 week treatment period using each pattern
Parkinson's Medication Use
During 1 week treatment period using each pattern
Rest Tremor - Off medication/On DBS
After 1 week treatment period using each pattern
Postural Tremor - Off medication/On DBS
After 1 week treatment period using each pattern
- +5 more secondary outcomes
Study Arms (4)
TOPS1 DBS
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order.
Interventions
TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
Standard is the pattern of stimulation that is usually delivered clinically by a DBS system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Florida
Gainesville, Florida, 32608, United States
Northwestern University
Chicago, Illinois, 60611, United States
Duke University
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participant and Outcomes Assessor blinded to DBS pattern in use
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 18, 2020
Study Start
July 27, 2020
Primary Completion
February 2, 2022
Study Completion
February 8, 2022
Last Updated
June 27, 2022
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share