Clinical Trials for Essential Tremor
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Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease.

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Understanding a Clinical trial

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease.

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.

The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

 Our Clinical Trial

The goal of this prospective, non-randomized, observational study is to assess the modifications in tremor score and in brain MR imaging after the treatment of medication-refractory tremor in patients with Essential Tremor with the Exablate® Neuro System.

A total of 10 subjects with confirmed medication-refractory movement disorders, specifically Essential Tremor eligible for MRgFUS Vim thalamotomy and who want to participate voluntary in this study will be included

Written informed consent will be obtained from each participating. The patient will be counselled concerning the nature of this observational study, and the risks and possible benefits to participation. This study will utilize a pre-treatment imaging exam to confirm the diagnosis, and to estimate location and size of target area, and acoustic access for treatment. Participation is fully voluntary.

  1. Men and women, between 18 and 80 years, inclusive.
  2. Patients who are able and willing to give consent and able to attend all study visits.
  3. A diagnosis of ET as confirmed from clinical history and examination by a Movement Disorder Neurologist.
  4. Tremor refractory to adequate trials of at least two medications, one of which should be either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.
  5. Vim nucleus of thalamus can be target by the Exablate® device. The Vim region of the thalamus must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from a line connecting the anterior and posterior commissures of the brain.

6. Able to communicate sensations during the Exablate® MRgFUS treatment.

  1. Postural or intention tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the Clinical Rating Scale for Tremor (CRST).
  2. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
  3. May have bilateral appendicular tremor.
  4. Significant disability due to Essential Tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities]).
  5. Inclusion and exclusion criteria have been agreed upon by two members of the medical team.
  1. Patients with unstable cardiac status including:
  •    Unstable angina pectoris on medication
  •    Patients with documented myocardial infarction within six months of protocol entry
  •    Congestive heart failure requiring medication (other than diuretic)
  •    Patients on anti-arrhythmic drugs
  1. Patients exhibiting any behaviour(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV within a 12 month period.
  2. Severe hypertension (diastolic BP > 100 on medication)
  3. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  4. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease.
  5. Severely impaired renal function (estimated glomerular filtration rate < 45ml/min/1.73 m2) or receiving dialysis.
  6. History of abnormal bleeding and/or coagulopathy.
  7. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or haemorrhage (e.g. statins) within one month of focused ultrasound procedure.
  8. Active or suspected acute or chronic uncontrolled infection.
  9. History of intracranial haemorrhage.
  10. Cerebrovascular disease (multiple CVA or CVA within 6 months).
  11. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time).
  12. Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema).
  13. Are participating or have participated in another clinical trial in the last 30 days.
  14. Patients unable to communicate with the investigator and staff.
  1. Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer’s disease.
  2. Anyone suspected to have the diagnosis of idiopathic Parkinson’s disease. This includes excluding anyone with the presence of parkinsonian features including bradykinesia rigidity, or postural instability. Subjects who exhibit only mild resting tremor but no other symptoms or signs of PD may be included.
  3. Presence of significant cognitive impairment as determined with a score = 24 on the Mini Mental Status Examination (MMSE).
  4. History of immunocompromise, including patient who is HIV positive.
  5. Known life-threatening systemic disease.
  6. Patients with a history of seizures within the past year.
  7. Patients with current or a prior history of any psychiatric illness will be excluded. Any presence or history of psychosis will be excluded. Patients with mood disorders including depression will be excluded. For the purpose of this study, we consider a significant mood disorder to include any patient who has:
  •    been under the care of a psychiatrist for over 3 months
  •    taken antidepressant medications for greater than 6 months
  •    has participated in cognitive-behavioural therapy
  •    been hospitalized for the treatment of a psychiatric illness
  •    received transcranial magnetic stimulation
  •    received electroconvulsive therapy
  1. Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimetre, abnormal level of PT, PTT or INR per local clinical standards) or documented coagulopathy.
  2. Patients with brain tumours.
  3. Any illness that in the investigator’s opinion preclude participation in this study.
  4. Pregnancy or lactation.
  5. Legal incapacity or limited legal capacity.
  6. Patients who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.