Pre-lemniscal Radiation Deep Brain Stimulation for ET

January 16, 2020 updated by: Medical College of Wisconsin
The hypothesis is that prelemniscal radiation (RaPRL) deep brain stimulation (DBS) is more effective for axial (head/neck/voice) tremor, and perhaps, appendicular tremor control in essential tremor patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. diagnosis of essential tremor based on clinical criteria established by the Essential Tremor Consortium
  2. Moderate or severe axial-dominant (head/neck/voice) tremor (Tremor Rating Scale [TRS] face, tongue, voice, head or trunk tremor score of 2 or above)
  3. May have bilateral appendicular tremor
  4. Tremor refractory to at least two medications, including primidone and propranolol
  5. Age between 21 and 75
  6. Male or Female
  7. Significant disability due to essential tremor despite medical treatment (TRS score of 2 or above in any one of the items 16-23 [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities])

Exclusion Criteria:

  1. Tremor due to other etiologies
  2. Pregnancy
  3. Presence of any other neurodegenerative disease
  4. Presence of significant cognitive impairment
  5. Presence of any medical condition that precludes neurological surgery
  6. Patients with another implanted stimulator or metallic implant, e.g. cochlear implant, cardiac pacemaker, spinal cord stimulator, aneurysm clips
  7. Patients who have a known need for future MRIs using a full body radio-frequency (RF) coil or a head transmit coil that extends over the chest area or that do not comply with Medtronic's "MRI Guidelines for Medtronic Deep Brain Simulation Systems"
  8. Patients with a history of seizures
  9. Patients with psychiatric illness that are not well controlled
  10. Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 125,000 per cubic millimeter, PT and PTT not within normal limits)
  11. Patients with brain tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
preleminiscal radiation deep brain stimulation
Radiation: Pre-lemniscal Radiation Deep Brain Stimulation
Active Comparator: 2
VIM deep brain stimulation
Radiation: Pre-lemniscal Radiation Deep Brain Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tremor rating scale axial score and total score
Time Frame: 3 months, 12 months and 24 months
3 months, 12 months and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life (SF 36 and clinical global impression of change)
Time Frame: 3 months, 12 months and 24 months
3 months, 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Serena W Hung, M.D., Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

January 19, 2011

Study Completion (Actual)

January 19, 2011

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00008047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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