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

Parkinson Disease Clinical Trial

— TOPS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04390867
• Other study ID #: 0152
• Status: Terminated
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: February 8, 2022

Study information

• Verified date: September 2021
• Source: Deep Brain Innovations LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 8, 2022
• Est. primary completion date: February 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• TOPS1 DBS
TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
• TOPS2 DBS
TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
• TOPS3 DBS
TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
• Standard DBS
Standard is the pattern of stimulation that is usually delivered clinically by a DBS system

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Deep Brain Innovations LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Study related adverse device effects	Reported AEs	After 1 week treatment period using TOPS1
Primary	Study related adverse device effects	Reported AEs	After 1 week treatment period using TOPS2
Primary	Study related adverse device effects	Reported AEs	After 1 week treatment period using TOPS3
Primary	Study related adverse device effects	Reported AEs	After 1 week treatment period using Standard
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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