Recruiting

Observational Study

Sponsor:

Abbott Medical Devices

Code:

NCT04071847

Conditions

Movement Disorders

Parkinson Disease

Essential Tremor

Tremor

Dystonia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation (DBS)

Study Details

Brief summary:

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.

Conditions

Movement Disorders

Parkinson Disease

Essential Tremor

Tremor

Dystonia

Study ID

NCT04071847

Start date

Nov 26, 2019

Status verified date

Jan, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.
2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.

Exclusion Criteria:

1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
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. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.
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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Deep brain stimulation

Subjects implanted with an Abbott DBS system

Interventions

Deep Brain Stimulation (DBS)

Deep brain stimulation therapy involves the delivery of electrical signals to targeted structures in the brain to modulate neural circuit activity, and has been used successfully for the treatment of various types of movement disorders, including Parkinson's disease (PD), disabling or essential tremor, and dystonia

Primary outcome measure

  • Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 6 months ]
  • Change from baseline to1 year in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to1 year ]
  • Change from baseline to 2 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 2 years ]
  • Change from baseline to 3 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 3 years ]
  • Change from baseline to 4 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 4 years ]
  • Change from baseline to 5 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [ Time Frame: Baseline to 5 years ]
  • Change from baseline to 6 months in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 6 months ]
  • Change from baseline to 1 year in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 1 year ]
  • Change from baseline to 2 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 2 years ]
  • Change from baseline to 3 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 3 years ]
  • Change from baseline to 4 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 4 years ]
  • Change from baseline to 5 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [ Time Frame: Baseline to 5 years ]
  • Change from baseline to 6 months in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 6 months ]
  • Change from baseline to 1 year in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 1 year ]
  • Change from baseline to 2 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 2 years ]
  • Change from baseline to 3 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 3 years ]
  • Change from baseline to 4 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 4 years ]
  • Change from baseline to 5 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale. [ Time Frame: Baseline to 5 years ]
  • Change from baseline to 6 months in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 6 months ]
  • Change from baseline to 1 year in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 1 year ]
  • Change from baseline to 2 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 2 years ]
  • Change from baseline to 3 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 3 years ]
  • Change from baseline to 4 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 4 years ]
  • Change from baseline to 5 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale. [ Time Frame: Baseline to 5 years ]
  • Incidence of device- and procedure-related serious adverse events at 6 months [ Time Frame: At 6 months ]
  • Incidence of device- and procedure-related serious adverse events at 1 year [ Time Frame: At 1 year ]
  • Incidence of device- and procedure-related serious adverse events at 2 years [ Time Frame: At 2 years ]
  • Incidence of device- and procedure-related serious adverse events at 3 years [ Time Frame: At 3 years ]
  • Incidence of device- and procedure-related serious adverse events at 4 years [ Time Frame: At 4 years ]
  • Incidence of device- and procedure-related serious adverse events at 5 years [ Time Frame: At 5 years ]

Central Contacts and Locations

Central contacts

Claudia Salazar, PhD

+1-650-647-3396claudia.salazar4@abbott.com

Shirisha Chiluka

972-526-4820Shirisha.Chiluka@abbott.com

Locations

University of South Florida - Department of Neurology

Recruiting

Tampa, Florida, United States, 33612

Contacts

Konrad Bach

727-798-3789kbach@health.usf.edu

Principal Investigator:

Yarema Bezchlibnyk, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Neepa Patel

312-563-2900Neepa_Patel@rush.edu

Kristy Urquhart

Kristy_M_Urquhart@rush.edu

Principal Investigator:

Neepa Patel, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Elizabeth Zauber, MD

szauber@iupui.edu

Andrea Hurt, RC

andhurt@iu.edu

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Anna Williford

502-852-7402anna.williford@louisville.edu

Principal Investigator:

Joseph Neimat, MD

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Adam Octavian, MD

518-262-6611adamo1@mail.amc.edu

Margaret Czerwinski, RN

518 262 0034czerwim@mail.amc.edu

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Sean Nagel, MD

216-444-2200

Ohio State Medical

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Barbara Changizi, MD

614-366-2420

University of Utah Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Julianna Dorsch

801-587-8804julianna.dorsch@hsc.utah.edu

Principal Investigator:

Paolo Moretti, MD

More Information

Sponsor

Abbott Medical Devices

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-01-08.