Pre-lemniscal Radiation Deep Brain Stimulation for ET

Essential Tremor Clinical Trial

Official title:

Pre-lemniscal Radiation Deep Brain Stimulation for ET

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00634478
• Other study ID #: PRO00008047
• Status: Withdrawn
• Phase: N/A
• Start date: October 2008
• Est. completion date: January 19, 2011

Study information

• Verified date: January 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 19, 2011
• Est. primary completion date: January 19, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Radiation:
• Pre-lemniscal Radiation Deep Brain Stimulation

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Plaha P, Patel NK, Gill SS. Stimulation of the subthalamic region for essential tremor. J Neurosurg. 2004 Jul;101(1):48-54. — View 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. — View Citation

Velasco F, Jiménez F, Pérez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tremor rating scale axial score and total score		3 months, 12 months and 24 months
Secondary	quality of life (SF 36 and clinical global impression of change)		3 months, 12 months and 24 months