Clinical trial: Deep Brain Stimulation Surgery for Movement Disorders (NCT01581580)

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.

        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:

          -  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

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

        Agree to undergo DBS if indicated to treat medically refractory movement disorder.

        EXCLUSION CRITERIA:

        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; active heart disease needing immediate
        intervention; active respiratory disease needing immediate intervention; uncorrected
        coagulation abnormalities or need for therapeutic anticoagulation which cannot be
        interrupted; current or pre-existing life-threatening respiratory disease, such as
        respiratory failure or ARDS.

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

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

          -  History of CVA, exposure to toxins, neuroleptics, or encephalitis

          -  Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze
             palsy, or orthostatic hypotension.

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

          -  Features atypical of idiopathic Parkinson s disease.

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

        Depression or evidenced by self-report on 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.

        Patients with tremor-dominant PD with Scans Without Evidence of Dopaminergic Effect (SWEDD)
        will be excluded based on clinical and historic information, including DaT functional
        imaging obtained during routine clinical evaluation of PD as needed.
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