Status:
WITHDRAWN
Pre-lemniscal Radiation Deep Brain Stimulation for ET
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Essential Tremor
Eligibility:
All Genders
21-75 years
Phase:
NA
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 pa...
Eligibility Criteria
Inclusion
- 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 \[speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities\])
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00634478
Start Date
October 1 2008
End Date
January 19 2011
Last Update
January 21 2020
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226