Pre-lemniscal Radiation Deep Brain Stimulation for ET

NCT00634478 | Withdrawn

• 1 other identifier: PRO00008047
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor

Keywords

essential tremor; deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Tremor rating scale axial score and total score

  3 months, 12 months and 24 months

Secondary Outcomes (1)

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

  3 months, 12 months and 24 months

Study Arms (2)

1

EXPERIMENTAL

preleminiscal radiation deep brain stimulation

Radiation: Pre-lemniscal Radiation Deep Brain Stimulation

2

ACTIVE COMPARATOR

VIM deep brain stimulation

Radiation: Pre-lemniscal Radiation Deep Brain Stimulation

Interventions

Pre-lemniscal Radiation Deep Brain Stimulation RADIATION

1; 2

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (8)

• 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.

  PMID: 16619653 BACKGROUND

• 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.

  PMID: 15834027 BACKGROUND

• 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.

  PMID: 8592222 BACKGROUND

• 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.

  PMID: 14663050 BACKGROUND

• 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.

  PMID: 15670376 BACKGROUND

• 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.

  PMID: 14567607 BACKGROUND

• 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.

  PMID: 11504105 BACKGROUND

• 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.

  PMID: 15255251 BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Serena W Hung, M.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: March 13, 2008
• Study Start: October 1, 2008
• Primary Completion: January 19, 2011
• Study Completion: January 19, 2011
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

US (1)