Use of Two Deep Brain Stimulation (DBS) Electrodes to Treat Post-Traumatic Tremor

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medtronic
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00954421
First received: July 27, 2009
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

The purpose of this research study is to:

  1. Determine whether deep brain stimulation (DBS) with two leads (very thin coiled wires) placed unilaterally (on one side of the brain) is beneficial to patients with multiple sclerosis (MS) tremor.
  2. Compare the two different locations of the DBS lead placement in effectiveness for treatment of muscle tremors that do not respond to treatment with medication caused by multiple sclerosis.
  3. Evaluate any side effects that may result from the two DBS leads.

Condition Intervention
Multiple Sclerosis
Device: Deep Brain Stimulation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Two DBS Electrodes to Treat Post-Traumatic Tremor

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • The target population distributions of Tremor Rating Scale scores [ Time Frame: baseline and six months after initiation of VIM and VO DBS ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2006
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multiple Sclerosis Tremor On VIM and VO Device: Deep Brain Stimulation
Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have an unequivocal diagnosis of MS resulting in disabling tremor as indicated by a score of at least 3 on the TRS baseline global assessments by the examiner and the patient.
  • The patient must have a history of an unsatisfactory response to medical management. Any patient will need to have tried and failed at least one drug from at least three of the four following medication classes: anticholinergics, muscle relaxants, benzodiazepines, and beta blockers. Alternatively, a patient may also qualify if tremor-suppressing medications are contraindicated due to a coexisting medical condition or drug allergy.
  • The MS patient must have disabling and medically refractory unilateral or bilateral upper extremity tremor. Patients with associated ipsilateral lower extremity tremor are not excluded.
  • The tremor must meet the following specific diagnostic criteria:

    • The tremor must be predominantly postural or action (versus resting) and have a rhythmic and/or ballistic characteristic.
    • The tremor may not have features that indicate a significant cerebellar etiology (i.e., non-prominent ataxia, dysdiadokokinesia, dysmetria).
    • The tremor must have been present and either stable or progressing for greater than one year.
    • The tremor must be disabling. Disabling is defined as significant impairment of the normal functions of daily life as indicated by a score of at least 5 on the Clinical Global Impression (CGI)-Severity scale.

Exclusion Criteria:

  • Significant medical disease that would excessively increase risk of peri-operative complications (significant cardiac or pulmonary disease, uncontrolled hypertension, inadequately treated major depression).
  • More than mild non-tremor cerebellar dysfunction (ataxia, dysmetria, dysdiadokokinesia).
  • Evidence of secondary/atypical movement disorder as suggested by presence of the following:

    • history of stroke(s)
    • exposure to toxins or neuroleptics
    • history of encephalitis
    • neurological signs of upper motor neuron disease, supranuclear gaze palsy, or significant orthostatic hypotension
  • MRI with significant evidence of severe brain atrophy or other prohibitive abnormalities (absence of thalamic target for DBS, lacunar infarcts, or iron deposits in the putamen).
  • Cognitive dysfunction as evidenced by a score of less than 120 on the Mattis Dementia Rating Scale (MDRS) Such patients will be excluded because significant dementia places the patient at high risk for surgery-induced deterioration of cognitive function, and such patients might have limited ability to accurately assess the impact of DBS.
  • Major psychiatric disorder on the Structured Clinical Interview for DSM-IV (SCID-IV).45 Patients with Major Depression within 3 months of entry into the study will be excluded. High rates of psychiatric co-morbidity can complicate any neurosurgical study. While the cleanest study would exclude patients with psycho-pathology, we do not believe this is realistic or practical, given the majority of patients with advanced movement disorders will suffer from some degree of anxiety or depression. We will screen patients for psychiatric disorders, treat disorders prior to DBS and admit patients who are psychiatrically stable for at least 3 months prior to entry (without active psychiatric diagnosis by SCID criteria).
  • Patients with any implanted device that precludes magnetic resonance imaging (MRI) will be excluded from this study. Examples of such devices include cochlear implants, spinal cord stimulators, many cardiac pacemakers, and some older aneurysm clips
  • Patients who have a known need for future MRIs or diathermy treatments will be excluded from this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954421

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Medtronic
Investigators
Principal Investigator: Kelly Foote, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00954421     History of Changes
Other Study ID Numbers: 461-2006, K23NS052557
Study First Received: July 27, 2009
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014