Clinical trial NCT00634478: Pre-lemniscal Radiation Deep Brain Stimulation for ET
Official title: Pre-lemniscal Radiation Deep Brain Stimulation for ET
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Essential Tremor
Keywords: essential tremor
deep brain stimulation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tremor rating scale axial score and total score
timeFrame: 3 months, 12 months and 24 months
Secondary outcomes:
measure: quality of life (SF 36 and clinical global impression of change)
timeFrame: 3 months, 12 months and 24 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Serena W Hung, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.