search
Back to results

Pre-lemniscal Radiation Deep Brain Stimulation for ET

Primary Purpose

Essential Tremor

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-lemniscal Radiation Deep Brain Stimulation
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor focused on measuring essential tremor, deep brain stimulation

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

preleminiscal radiation deep brain stimulation

VIM deep brain stimulation

Outcomes

Primary Outcome Measures

Tremor rating scale axial score and total score

Secondary Outcome Measures

quality of life (SF 36 and clinical global impression of change)

Full Information

First Posted
January 9, 2008
Last Updated
January 16, 2020
Sponsor
Medical College of Wisconsin
search

1. Study Identification

Unique Protocol Identification Number
NCT00634478
Brief Title
Pre-lemniscal Radiation Deep Brain Stimulation for ET
Official Title
Pre-lemniscal Radiation Deep Brain Stimulation for ET
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in recruitment. Funding issues.
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 19, 2011 (Actual)
Study Completion Date
January 19, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
essential tremor, deep brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
preleminiscal radiation deep brain stimulation
Arm Title
2
Arm Type
Active Comparator
Arm Description
VIM deep brain stimulation
Intervention Type
Radiation
Intervention Name(s)
Pre-lemniscal Radiation Deep Brain Stimulation
Primary Outcome Measure Information:
Title
Tremor rating scale axial score and total score
Time Frame
3 months, 12 months and 24 months
Secondary Outcome Measure Information:
Title
quality of life (SF 36 and clinical global impression of change)
Time Frame
3 months, 12 months and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of essential tremor based on clinical criteria established by the Essential Tremor Consortium 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) May have bilateral appendicular tremor Tremor refractory to at least two medications, including primidone and propranolol Age between 21 and 75 Male or Female 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: Tremor due to other etiologies Pregnancy Presence of any other neurodegenerative disease Presence of significant cognitive impairment Presence of any medical condition that precludes neurological surgery Patients with another implanted stimulator or metallic implant, e.g. cochlear implant, cardiac pacemaker, spinal cord stimulator, aneurysm clips 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" Patients with a history of seizures Patients with psychiatric illness that are not well controlled 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) Patients with brain tumors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serena W Hung, M.D.
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16619653
Citation
Pahwa R, Lyons KE, Wilkinson SB, Simpson RK Jr, Ondo WG, Tarsy D, Norregaard T, Hubble JP, Smith DA, Hauser RA, Jankovic J. Long-term evaluation of deep brain stimulation of the thalamus. J Neurosurg. 2006 Apr;104(4):506-12. doi: 10.3171/jns.2006.104.4.506.
Results Reference
background
PubMed Identifier
15834027
Citation
Putzke JD, Uitti RJ, Obwegeser AA, Wszolek ZK, Wharen RE. Bilateral thalamic deep brain stimulation: midline tremor control. J Neurol Neurosurg Psychiatry. 2005 May;76(5):684-90. doi: 10.1136/jnnp.2004.041434.
Results Reference
background
PubMed Identifier
8592222
Citation
Benabid AL, Pollak P, Gao D, Hoffmann D, Limousin P, Gay E, Payen I, Benazzouz A. Chronic electrical stimulation of the ventralis intermedius nucleus of the thalamus as a treatment of movement disorders. J Neurosurg. 1996 Feb;84(2):203-14. doi: 10.3171/jns.1996.84.2.0203.
Results Reference
background
PubMed Identifier
14663050
Citation
Kumar R, Lozano AM, Sime E, Lang AE. Long-term follow-up of thalamic deep brain stimulation for essential and parkinsonian tremor. Neurology. 2003 Dec 9;61(11):1601-4. doi: 10.1212/01.wnl.0000096012.07360.1c.
Results Reference
background
PubMed Identifier
15670376
Citation
Kitagawa M, Murata J, Uesugi H, Kikuchi S, Saito H, Tashiro K, Sawamura Y. Two-year follow-up of chronic stimulation of the posterior subthalamic white matter for tremor-dominant Parkinson's disease. Neurosurgery. 2005 Feb;56(2):281-9; discussion 281-9. doi: 10.1227/01.neu.0000148167.49105.a3.
Results Reference
background
PubMed Identifier
14567607
Citation
Murata J, Kitagawa M, Uesugi H, Saito H, Iwasaki Y, Kikuchi S, Tashiro K, Sawamura Y. Electrical stimulation of the posterior subthalamic area for the treatment of intractable proximal tremor. J Neurosurg. 2003 Oct;99(4):708-15. doi: 10.3171/jns.2003.99.4.0708.
Results Reference
background
PubMed Identifier
11504105
Citation
Velasco F, Jimenez F, Perez ML, Carrillo-Ruiz JD, Velasco AL, Ceballos J, Velasco M. Electrical stimulation of the prelemniscal radiation in the treatment of Parkinson's disease: an old target revised with new techniques. Neurosurgery. 2001 Aug;49(2):293-306; discussion 306-8. doi: 10.1097/00006123-200108000-00009.
Results Reference
background
PubMed Identifier
15255251
Citation
Plaha P, Patel NK, Gill SS. Stimulation of the subthalamic region for essential tremor. J Neurosurg. 2004 Jul;101(1):48-54. doi: 10.3171/jns.2004.101.1.0048.
Results Reference
background

Learn more about this trial

Pre-lemniscal Radiation Deep Brain Stimulation for ET

We'll reach out to this number within 24 hrs