Clinical trial: Dual Lead Thalamic Deep Brain Recording (DBR)-DBS Interface for Closed Loop Control of Severe Essential Tremor (NCT04212780)

Eligibility criteria:
Inclusion Criteria:

          -  Patient gives an informed consent.

          -  Patient is over 21 years of age.

          -  Patient is diagnosed with a postural-intention (essential) tremor for at least 3
             years, meets diagnostic criteria for ET, has been evaluated and examined by a movement
             disorders fellowship trained neurologist, and is being treated with traditional VIM
             DBS therapy.

          -  Patient has no evidence of non-ET central nervous system disease or injury and has had
             a significantly disabling, upper extremity tremor despite ongoing VIM DBS therapy for
             at least three (3) months prior to DBS revision surgery.

          -  Patient has a postural or kinetic tremor severity score of at least 2 out of 4 in the
             extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for
             Tremor (TRS) despite ongoing VIM DBS therapy.

          -  Patient has a TRS score of 2 or above in any one of the items 16-23 from the
             Disability subsection of the TRS: speaking, feeding other than liquids, bringing
             liquids to mouth, hygiene, dressing, writing, working and social activities despite
             ongoing VIM DBS therapy.

          -  Patient's tremor is refractory to adequate trials of at least two medications, one of
             which should be either propranolol or primidone. Proof of this is not required for
             patients with a current device that is being removed and replaced with a new device.
             An adequate medication trial is defined as a therapeutic dose of each medication or
             the development of side effects as the medication dose is titrated.

          -  Patient is available for appropriate follow-up times for the length of the study.

        Exclusion Criteria:

          -  Any previous neurosurgical intervention other than VIM DBS, including ablative brain
             lesions for tremor suppression.

          -  Medication related movement disorders.

          -  Any suspicion of Parkinson's disease, including presence of Parkinsonian features such
             as bradykinesia, rigidity, or postural instability.

          -  Any behaviors consistent with alcohol or substance abuse as defined by the criteria
             outlined in Diagnostic and Statistical Manual of Mental Disorders (DSM-V).

          -  Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney
             disease, continuous neurological disease, hematological disease, or frailty that
             impact tolerability of the surgery as judged by the screening physicians.

          -  Abnormal brain MRI including hydrocephalus, stroke, structural lesions, demyelinating
             lesions, or infectious lesions. Also excluded will be subjects with severe brain
             atrophy.

          -  Any uncontrolled symptoms or signs of increased intracranial pressure (e.g., headache,
             nausea, vomiting, lethargy, papilledema).

          -  A history of seizures within the past year.

          -  A dementia rating scale score (DRS) <130 signifying significant cognitive dysfunction
             and a potential for inability to cooperate with tasks involved in the study.

          -  Any attempt or intent of suicide during the previous six months.

          -  Presence or history of psychosis.

          -  Any person known to have abnormal coagulation or any medications which interfere with
             coagulation

          -  Significant untreated or unstable mood disorders including depression. This will be
             determined by the Neuropsychological team during FastTrack and by the Neurologist

          -  In addition, patients who are pregnant or plan to become pregnant will be excluded
             from this study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 99 Years

Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment