Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2008-10-31
2011-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
preleminiscal radiation deep brain stimulation
Pre-lemniscal Radiation Deep Brain Stimulation
2
VIM deep brain stimulation
Pre-lemniscal Radiation Deep Brain Stimulation
Interventions
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Pre-lemniscal Radiation Deep Brain Stimulation
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
75 Years
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Principal Investigators
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Serena W Hung, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PRO00008047
Identifier Type: -
Identifier Source: org_study_id
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