Deep Brain Stimulation (DBS) for the Suppression of Tremor

NCT02087046 | Completed Results DMC

• 1 other identifier: C-04-02
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Tremor; Action Tremor; Essential Tremor; Tremor, Limb

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer

  The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

  Day 180

• Primary Safety Endpoint: Percentage of Participants With Device-related or Procedure Related Adverse Events

  Percentage of device-related or procedure related adverse events will be assessed within 6 months following the initial unilateral implant. All such adverse events will be counted for 180 days following surgery or until the day of the second implant, which ever comes first.

  Within 180 days following the initial implant

Secondary Outcomes (65)

• Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician

  Baseline

• Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician

  Day 90

• Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician

  Day 180

• Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician

  Day 365

• Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician

  Day 90

Study Arms (1)

Stimulation

OTHER

ANS Totally Implantable Deep Brain Stimulation System

Device: ANS Totally Implantable Deep Brain Stimulation System

Interventions

ANS Totally Implantable Deep Brain Stimulation System DEVICE

ANS Totally Implantable Deep Brain Stimulation System will be implanted in the VIM nucleus of the thalamus

Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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);

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (12)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Loma Linda University School of Medicine

Loma Linda, California, 92354, United States

Location

Pacific Hills Neurosurgery Medical Group

Pasadena, California, 91105, United States

Location

University of San Francisco

San Francisco, California, 94122, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Oakwood Hospital

Dearborn, Michigan, 48124, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14618, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Neurology Specialists of Dallas

Dallas, Texas, 75231, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Tremor; Essential Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases

Results Point of Contact

• Title: Clinical Research Scientist
• Organization: Abbott

mike.frassica@abbott.com

972-309-8000

Study Officials

• Edward Karst

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: October 1, 2005
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2017
• Last Updated: April 25, 2023
• Results First Posted: February 26, 2021

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)