Clinical trial: Deep Brain Stimulation (DBS) for the Suppression of Tremor (NCT02087046)

Eligibility criteria:
Inclusion criteria:

          1. Patient or authorized representative has signed an informed consent.

          2. Patient is over 18 years of age.

          3. Patient is diagnosed with essential tremor for at least 3 years.

          4. Patient has a 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. Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the
             extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for
             Tremor.

          6. Patient will maintain a constant dose of anti-tremor medication indicated as best
             medical management for one (1) month prior to enrollment in study.

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

        Exclusion criteria:

          1. Patient is not surgical candidate;

          2. Patient has other clinically or medically significant disease;

          3. Patient has any neurological injury or disease other than essential tremor;

          4. Patient has any condition requiring repeated MRI scans;

          5. Patient has any condition requiring diathermy;

          6. Patients on anticoagulant medications;

          7. Patient has untreated clinically significant depression;

          8. Patient has had an electrical or electromagnetic implant (cochlear prosthesis,
             pacemaker etc);

          9. Patient has had a prior thalamotomy or surgical ablation procedure in either side of
             the brain;

         10. Patient has dementia interfering with their ability to co-operate or comply with study
             requirements or comprehend the informed consent (mini-mental exam score <24);

         11. Patient abuses drugs or alcohol;

         12. Patient has had botulinum toxin injections in the six (6) months prior to enrollment;

         13. Patient has a history of cranial surgery;

         14. Patient has a history of seizures;

         15. Patient has any metallic implants that may interfere with the functioning of the
             device (e.g. aneurysm clips);

         16. Patient has a history of stimulation intolerance in any area of the body;

         17. Patient is a female of child bearing potential with a positive urine pregnancy test or
             not using adequate contraception.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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? 1