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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390867
Recruitment Status : Terminated (Business decision on June 2, 2022)
First Posted : May 18, 2020
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Deep Brain Innovations LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: TOPS1 DBS Device: TOPS2 DBS Device: TOPS3 DBS Device: Standard DBS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Random order of presentation of all three TOPS and Standard DBS in each participant
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participant and Outcomes Assessor blinded to DBS pattern in use
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Cross-Over Home-Use Study of TOPS® DBS for the Treatment of Parkinson's Disease
Actual Study Start Date : July 27, 2020
Actual Primary Completion Date : February 2, 2022
Actual Study Completion Date : February 8, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS [ Time Frame: 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.

  2. Study related adverse device effects [ Time Frame: After 1 week treatment period using TOPS1 ]
    Reported AEs

  3. Study related adverse device effects [ Time Frame: After 1 week treatment period using TOPS2 ]
    Reported AEs

  4. Study related adverse device effects [ Time Frame: After 1 week treatment period using TOPS3 ]
    Reported AEs

  5. Study related adverse device effects [ Time Frame: After 1 week treatment period using Standard ]
    Reported AEs


Secondary Outcome Measures :
  1. Home Use "On Time" [ Time Frame: 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

  2. Patient Global Impression of Improvement Rating [ Time Frame: 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

  3. Parkinson's Medication Use [ Time Frame: 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

  4. Rest Tremor - Off medication/On DBS [ Time Frame: After 1 week treatment period using each pattern ]
    Measured using Kinesia One system. Average difference between the best TOPS and Standard

  5. Postural Tremor - Off medication/On DBS [ Time Frame: After 1 week treatment period using each pattern ]
    Measured using Kinesia One system. Average difference between the best TOPS and Standard.

  6. Bradykinesia - Off medication/On DBS [ Time Frame: After 1 week treatment period using each pattern ]
    Measured using Kinesia One system. Average difference between the best TOPS and Standard.

  7. Type and severity of side effects of stimulation [ Time Frame: 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

  8. Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - On medication/On DBS [ Time Frame: 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.

  9. Clinical Global Impression of Improvement Rating [ Time Frame: 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

  10. Test Pattern Use Count [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390867


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Deep Brain Innovations LLC
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Deep Brain Innovations LLC
ClinicalTrials.gov Identifier: NCT04390867    
Other Study ID Numbers: 0152
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Deep Brain Innovations LLC:
Deep Brain Stimulation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases