Clinical trial: Deep Brain Stimulation Therapy in Movement Disorders (NCT02119611)

Eligibility criteria:
-  INCLUSION CRITERIA:

        To be eligible for entry into the study, candidates must meet all the following criteria:

          -  Be 18 years of age or older.

          -  Can speak and understand sufficient English or Spanish to provide informed consent and
             complete study assessments validly.

          -  Able to provide informed consent.

          -  Have a clinical diagnosis of idiopathic PD, primary dystonia, or ET:

               -  The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and
                  confirmed by the Movement Disorders Neurologists in the NIH Parkinson Clinic.

               -  The diagnosis of primary (generalized or segmental), hemidystonia, or cervical
                  dystonia will be confirmed on clinical examination in the NIH Movement Disorders
                  Clinic.

               -  The diagnosis of ET will be confirmed on clinical examination in the NIH Movement
                  Disorders Clinic (the diagnosis of ET will be based on bilateral, largely
                  symmetric postural or kinetic tremor involving hands and forearms that is visible
                  and persistent. Additional or isolated tremor in head may be present but there
                  should be the absence of abnormal posturing).

          -  History of appropriate response to dopaminergic medication, with at least a 30%
             improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD
             patients. OR

             --Patients with tremor-dominant PD that do not respond to dopaminergic therapy and
             that exhibit a tremor score of at least 2 for tremor severity on at least one side of
             the body on the motor UPDRS examination.

          -  Unsatisfactory clinical response to maximal medical management (with trials of both
             higher and lower doses of drugs), including:

          -  For PD patients:

               -  good benefit from dopaminergic medication but associated with insufficient
                  duration of action or unacceptable side-effects OR

               -  intractable disabling motor fluctuations (severe off periods, dyskinesias, or
                  freezing spells) OR

          -  For ET and dystonia:

             --intractable symptoms of ET or dystonia impacting at least 2 activities of daily
             living.

          -  Interested in being evaluated to undergo DBS, if indicated, to treat medically
             refractory movement disorder or Patients already implanted with DBS for continued
             management

        EXCLUSION CRITERIA:

        For those who have not had DBS:

        Candidates will be excluded if they meet any of the following criteria:

          -  Clinically significant medical disease that would increase the risk of developing pre-
             or postoperative complications, including but not limited to uncontrolled systemic
             hypertension with values above 170/100; unstable heart disease; unstable respiratory
             disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation
             which cannot be interrupted;

          -  Evidence of secondary or atypical parkinsonism/dystonia/tremor as suggested by:

               1. History of stroke, exposure to toxins, neuroleptics, or encephalitis

               2. Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear
                  gaze palsy, or multiple systems atrophy.

               3. MR-imaging with evidence indicative of secondary disease such as tumor, or
                  stroke, which could cause the movement disorder.

          -  Dementia as evidenced by formal neuropsychological evaluation, Mattis Dementia Rating
             Scale (DRS-2) score, and clinical evaluations.

          -  Unable to complete cognitive assessments and testing necessary to adequately evaluate
             risks and benefits of surgery.

          -  Depression or anxiety as evidenced by self-report or the Beck Depression Inventory-2
             (score above 20)

          -  Unable to undergo MR-imaging because of implanted pacemakers, medication pumps,
             aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or
             cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments
             in the eye that welders and other metal workers may have, or if candidates are
             uncomfortable in small closed spaces (have claustrophobia), or cannot lie comfortably
             on their back for up to one hour.

          -  Pregnant women.

          -  Otherwise not eligible for DBS surgery, for example known inability to undergo
             anesthesia

        For those who have had DBS:

        -Contra-indications for
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