Pre-lemniscal Radiation Deep Brain Stimulation for ET

Withdrawn before enrolling · Not applicable

Conditions studied: Essential Tremor

In brief

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.

Key facts

Study ID

NCT00634478

Run by

Medical College of Wisconsin

People needed

0

Starts

2008-10-01

Expected to finish

2011-01-19

Last updated by the study team

2020-01-21

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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