The University of Texas Health Science Center at Houston is recruiting patients for a study to help boost the understanding of deep brain stimulation (DBS) for essential tremor. Led by Dr. Albert Fenoy, associate professor of neurosurgery at McGovern Medical School at UTHealth, the study is being funded by a $2.1 million grant from the National Institutes of Health (NIH).
With DBS, electrical stimulation is delivered to the brain through an electrode implanted deep into the VIM nucleus of the thalamus. The implanted electrode is connected to a neurostimulator which provides the appropriate amount of electrical stimulation to control tremor. However, over time its effectiveness can decrease due to ET progression. So the volume can be adjusted to compensate but can lead to side effects such as worsening of balance, or ataxia in up to 20 percent of patients. This study will seek to discover if the stimulation is modulating something in the cerebellum which is causing this.
A total of 72 patients are being recruited for the study. Each will undergo DBS for essential tremor and will be followed for two years.
Eligibility criteria includes:
| Age: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
Inclusion Criteria:
- the diagnosis of essential tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
- distal appendicular tremor, with minimal proximal component
- tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
- tremor judged to be severely impacting their quality of life.
Exclusion Criteria:
- significant neurological disorder
- significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
- severe psychiatric illness with suicidal ideations
- previous surgery to destroy the target region of the brain
- surgical contraindications to DBS
- current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time)
- family history of hereditary neurologic disorder, besides essential tremors ET
- floating metallic objects in the body
- pregnancy
- alcohol or substance abuse/dependence in the past 6 months.
To learn more or to see if you qualify to take part in the study, email albert.j.fenoy@uth.tmc.edu or susan.m.pouliot@uth.tmc.edu, or call (713) 486-7780 or (713) 486-8000. Learn more on the clinicaltrials.gov website here.