RECRUITING

Abbott DBS Post-Market Study of Outcomes for Indications Over Time

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Conditions

Movement DisordersParkinson DiseaseEssential TremorTremorDystoniaPrimary DystoniaSecondary Dystonia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

Official Title

Abbott DBS Post-Market Study of Outcomes for Indications Over Time

Quick Facts

Study Start:2019-11-26
Study Completion:2030-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04071847

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.
  2. 2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.
  1. 1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
  2. 2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
  3. 3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.
  4. 4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.

Contacts and Locations

Study Contact

Natalie Brill, PhD
CONTACT
+15122864383
Natalie.Brill@abbott.com
Shirisha Chiluka
CONTACT
972-526-4820
Shirisha.Chiluka@abbott.com

Principal Investigator

Devyani Nanduri
STUDY_DIRECTOR
Abbott Medical Devices Neuromodulation

Study Locations (Sites)

University of Aizona Health Sciences
Tucson, Arizona, 85274
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California at Davis
Sacramento, California, 95817
United States
Colorado Neurodiagnostics
Littleton, Colorado, 80120
United States
Neurosurgery One
Littleton, Colorado, 80122
United States
University of Miami Hospital
Miami, Florida, 33136
United States
University of South Florida - Department of Neurology
Tampa, Florida, 33612
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Kansas University Medical Center
Kansas City, Kansas, 66160
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Willis-Knighton Medical Center
Shreveport, Louisiana, 71103
United States
Beth Israe Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Albany Medical Center
Albany, New York, 12208
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44106
United States
Ohio State Medical
Columbus, Ohio, 43210
United States
Wright State University & Premier Health
Fairborn, Ohio, 45324
United States
Center for Interventional Pain & Spine
Exton, Pennsylvania, 19341
United States
Thomas Jefferson Department or Neurosurgery
Philadelphia, Pennsylvania, 19107
United States
Allegheny General Hospital Department of Neurosurgery
Pittsburgh, Pennsylvania, 15212
United States
Texas Movement Disorder Specialist
Georgetown, Texas, 78628
United States
University of Utah Hospital
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Devyani Nanduri, STUDY_DIRECTOR, Abbott Medical Devices Neuromodulation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-26
Study Completion Date2030-09

Study Record Updates

Study Start Date2019-11-26
Study Completion Date2030-09

Terms related to this study

Additional Relevant MeSH Terms

  • Movement Disorders
  • Parkinson Disease
  • Essential Tremor
  • Tremor
  • Dystonia
  • Primary Dystonia
  • Secondary Dystonia