Deep Brain Stimulation (DBS) for the Suppression of Tremor

Completed · Not applicable

Conditions studied: Tremor, Action Tremor, Essential Tremor, Tremor, Limb

In brief

The purpose of the proposed study is to demonstrate the safety and efficacy of the ANS Totally Implantable Deep Brain Stimulation System in the VIM nucleus of the thalamus implanted for the treatment of tremor due to essential tremor. This study will be included in the Pre-Market Approval Application to support the safety of this device in use.

Key facts

Study ID: NCT02087046
Run by: Abbott Medical Devices
People needed: 127
Starts: 2005-10-01
Expected to finish: 2017-12-01
Last updated by the study team: 2023-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient or authorized representative has signed an informed consent.
Patient is over 18 years of age.
Patient is diagnosed with essential tremor for at least 3 years.
Patient has a disabling medical-refractory upper extremity tremor with no evidence of supraspinal central nervous system disease or injury (tremor not adequately controlled by medications for at least three (3) months before implant).
Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor.
Patient will maintain a constant dose of anti-tremor medication indicated as best medical management for one (1) month prior to enrollment in study.
Patient is available for appropriate follow-up times for the length of the study.

You may not qualify if…

Patient is not surgical candidate;
Patient has other clinically or medically significant disease;
Patient has any neurological injury or disease other than essential tremor;
Patient has any condition requiring repeated MRI scans;
Patient has any condition requiring diathermy;
Patients on anticoagulant medications;
Patient has untreated clinically significant depression;
Patient has had an electrical or electromagnetic implant (cochlear prosthesis, pacemaker etc);
Patient has had a prior thalamotomy or surgical ablation procedure in either side of the brain;
Patient has dementia interfering with their ability to co-operate or comply with study requirements or comprehend the informed consent (mini-mental exam score <24);
Patient abuses drugs or alcohol;
Patient has had botulinum toxin injections in the six (6) months prior to enrollment;
Patient has a history of cranial surgery;
Patient has a history of seizures;
Patient has any metallic implants that may interfere with the functioning of the device (e.g. aneurysm clips);
Patient has a history of stimulation intolerance in any area of the body;
Patient is a female of child bearing potential with a positive urine pregnancy test or not using adequate contraception.

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Loma Linda University School of Medicine — Loma Linda, California, United States
Pacific Hills Neurosurgery Medical Group — Pasadena, California, United States
University of San Francisco — San Francisco, California, United States
University of Florida — Gainesville, Florida, United States
Mayo Clinic — Jacksonville, Florida, United States
Oakwood Hospital — Dearborn, Michigan, United States
Columbia University Medical Center — New York, New York, United States
University of Rochester — Rochester, New York, United States
Vanderbilt University — Nashville, Tennessee, United States
Neurology Specialists of Dallas — Dallas, Texas, United States
Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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