Clinical trial: Responsive Deep Brain Stimulator for Essential Tremor (NCT02649166)

Eligibility criteria:
Inclusion Criteria:

          1. You provide informed consent.

          2. You are over 21 years of age.

          3. You are diagnosed with a postural-intention (essential) tremor for at least 3 years
             and meet strict diagnostic criteria and have been seen and examined by a movement
             disorders fellowship trained neurologist.

          4. You have had a significant disabling medical-refractory upper extremity tremor with no
             evidence of supraspinal central nervous system disease or injury (tremor not
             adequately controlled by medications for at least three (3) months before implant).

          5. You have had 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 (CRST).

          6. You have had a CRST score of 2 or above in any one of the items 16-23 from the
             Disability subsection of the CRST: speaking, feeding other than liquids, bringing
             liquids to mouth, hygiene, dressing, writing, working and social activities.

          7. Your tremor is refractory adequate trials of at least two medications, one of which
             should be either propranolol or primidone. 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.

          8. You are available for appropriate follow-up times for the length of the study.

        Exclusion Criteria:

          1. Any previous neurosurgical intervention including deep brain stimulation or ablative
             brain lesions.

          2. Medication related movement disorders.

          3. Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such
             as bradykinesia, rigidity, or postural instability.

          4. Any behaviors consistent with ethanol or substance abuse as defined by the criteria
             outlined in DSM-V.

          5. 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.

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

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

          8. A history of seizures within the past year.

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

         10. Any attempt or intent of suicide in the last six months.

         11. Presence or history of psychosis.

         12. Significant or active mood disorders including depression. For the purpose of this
             study, we consider a significant mood disorder to include any subject who has:

               1. Scores ≥ 20 on the Patient Health Questionnaire - 9 (PHQ-9).

               2. Currently under the care of a psychiatrist

               3. Currently participating in cognitive-behavioral therapy

               4. Been hospitalized for the treatment of a psychiatric illness within 12 months

               5. Ever received transcranial magnetic stimulation

               6. Ever received electroconvulsive therapy

        n. 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.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.


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