Pre-lemniscal Radiation Deep Brain Stimulation for ET

Medical College of Wisconsin

Status: Withdrawn

Conditions: Essential Tremor

Treatments: Radiation: Pre-lemniscal Radiation Deep Brain Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00634478

PRO00008047

Details and patient eligibility

About

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.

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

1

Experimental group

Description:

preleminiscal radiation deep brain stimulation

Treatment:

Radiation: Pre-lemniscal Radiation Deep Brain Stimulation

2

Active Comparator group

Description:

VIM deep brain stimulation

Treatment:

Radiation: Pre-lemniscal Radiation Deep Brain Stimulation