Essential Tremor
Conditions
Keywords
essential tremor, deep brain stimulation
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.
Interventions
RADIATIONPre-lemniscal Radiation Deep Brain Stimulation
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tremor rating scale axial score and total score | 3 months, 12 months and 24 months |
Secondary
| Measure | Time frame |
|---|---|
| quality of life (SF 36 and clinical global impression of change) | 3 months, 12 months and 24 months |
Countries
United States
Outcome results
None listed