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Withdrawn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
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring essential tremor, deep brain stimulation
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
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
NCT ID
NCT00634478
First Posted
January 9, 2008
Last Updated
January 16, 2020
Sponsor
Medical College of Wisconsin
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
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Pre-lemniscal Radiation Deep Brain Stimulation for ET
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