Clinical trial: Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET) (NCT02909907)

Eligibility criteria:
Inclusion Criteria:

          1. Age 18 and over, male or female patient with (ET) involving at least their dominant
             hand, as diagnosed by a movement disorders neurologist.

          2. Having bothersome hand tremor in dominant hand with a hand TRS ≥2

          3. On stable medications during last 30 days prior to enrollment.

        Exclusion Criteria:

          1. Presence of secondary causes of tremor, such as dystonia and parkinsonism

          2. Any contraindication to botulinum toxin injections (e.g. motor neuron disease,
             neuromuscular junction disease, etc.)

          3. History of surgical treatment for (ET).

          4. Dementia as defined by DSM-V criteria

          5. Patients with suboptimally treated depression and significant depressive symptoms as
             defined by a PHQ-9 score of ≥15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild
             depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27
             Severe depression). Antidepressant medications, prescribed for depression or anxiety,
             will be allowed if the patient has been on a stable dose for at least 30 days.

          6. Patients with suboptimally treated anxiety and significant anxiety symptoms as defined
             by a GAD-7 score of ≥15 (GAD-7 scores 0-4: minimal anxiety; 5-9: mild anxiety; 10-14:
             moderate anxiety; 15-21: severe anxiety). Anti-anxiety medications, prescribed for
             anxiety, will be allowed if the patient has been on a stable dose for at least 30
             days.

          7. Significant renal, hepatic, cardiac and thyroid disease
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? Entailment