Clinical trial: Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders (NCT04725045)

Eligibility criteria:
Inclusion Criteria for PD:

          -  Diagnosis of idiopathic Parkinson's disease where the diagnosis was made by a Movement
             Disorder Specialist according to the MDS criteria of 2015, with a Hoehn and Yahr scale
             (H&Y) of at least 2 (bilateral involvement).

          -  Onset of the symptoms more than five years ago.

          -  MDS-UPDRS-III score of ≥30 without medication or DBS.

          -  Electrodes are implanted in target area STN.

        Inclusion Criteria for ET:

          -  Patient is diagnosed with essential tremor by a Movement Disorder Specialist.

          -  Diagnosis since more than 3 years.

          -  Patient has a disabling medical-refractory upper extremity tremor without medication
             or DBS.

          -  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 without medication or DBS.

          -  Electrodes are implanted in target area VIM.

        General Inclusion Criteria:

          -  Post-op the implanted electrodes pass an integrity check, i.e. no open or shorted
             electrodes.

          -  Stable medications

          -  Lack of dementia or depression.

          -  Patient is willing and able to comply with all visits and study related procedures

          -  Patient understands the study requirements and the treatment procedures and provides
             written informed consent before any study-specific tests or procedures are performed.

          -  Patient can tolerate at least 12 hours OFF medication and per clinical judgement be
             able to perform all study related procedures

        Exclusion Criteria:

          -  Any significant psychiatric problems, including unrelated clinically significant
             depression.

          -  Any current drug or alcohol abuse.

          -  Any history of recurrent or unprovoked seizures.

          -  Have any significant medical condition that is likely to interfere with study
             procedures or likely to confound evaluation of study endpoints, including any terminal
             illness with survival <12 months.
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.
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