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

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: TOPS1 DBS; Device: TOPS2 DBS; Device: TOPS3 DBS; Device: Standard DBS

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Deep Brain Innovations LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): February 2, 2022
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 0152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No