Dystonia, Essential Tremor, Parkinson's Disease
Conditions
Keywords
FUS, focused ultrasound, functional brain disorder, neuropathic pain, movement disorders, malignant brain tumors
Brief summary
The aim of this study is to asses the efficacy and the clinical safety of the transcranial magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec Ltd. for functional neurosurgery in the treatment of movement disorders. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create microthalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology and will serve as a basis for the clinical introduction of MR-guided ultrasound neurosurgery.
Interventions
Non-invasive brain intervention using MR-guided focused ultrasound
Sponsors
University Children's Hospital, Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women, between 18 and 80 years, inclusive. * Patients who are able and willing to give consent and able to attend all study visits. * A diagnosis of a MD, such as Essential Tremor (ET), Idiopathic Parkinson's diseases or primary Dystonia as confirmed from clinical history and examination by a movement disorder neurologist. * A MD refractory to adequate medical treatment, or in whom the indication for Deep Brain Stimulation (DBS) would be given, but DBS cannot be performed because of medical comorbidities or medical reasons, or because the patient clearly confirms by written statement that he does not want to undergo DBS for personal reasons (PD: increasing motor fluctuations albeit optimal medical treatment & unbearable side effects of medication; ET: failure of adequate tremor control with Propranolol and Primidone alone and in combination; Dystonia: dystonia or pain not controlled by oral medication). 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. * Either the medial thalamic nuclei or the subthalamic or pallidal areas can be target by the ExAblate device. The target region must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from landmarks, using the Stereotactic Atlas of the Human Thalamus and Basal Ganglia by Anne Morel, 39 analogous to our first clinical FUS study on patients with chronic pain 33. * Able to communicate sensations during the ExAblate MRgFUS treatment * Stable doses of all medications for 30 days prior to study entry and for the duration of the study. * Significant disability due to MD despite medical treatment (speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities) * Inclusion and
Exclusion criteria
have been agreed upon by two members of the medical team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Size | 3 months | Size of lesion in the target area for each sonication as a function of applied energy/temperature. |
| Patient Safety | 3 months | Number of Patients with Adverse Events as a Measure of Safety and Tolerability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy and QOL | 3 months | Efficacy and QOL will be quantified on respective rating scales (specified in protocol). |
Countries
Switzerland
Outcome results
None listed