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

NCT04390867 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-06-27

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

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

Sponsors & Collaborators

  • Deep Brain Innovations LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2022-02-02
Completion
2022-02-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390867 on ClinicalTrials.gov