Essential Tremor Clinical Trial
Official title:
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
Verified date | August 2013 |
Source | InSightec |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
Status | Completed |
Enrollment | 6 |
Est. completion date | July 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 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 7. Postural or intention tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the CRST rating scale. 8. Stable doses of all medications for 30 days prior to study entry and for the duration of the study. 9. May have bilateral appendicular tremor 10. 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]) 11. Inclusion and exclusion criteria have been agreed upon by two members of the medical team. Exclusion Criteria: 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 2. Alcohol or drug abuse within the past 6 months 3. Severe hypertension (diastolic BP > 100 on medication) 4. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. 5. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 6. Severely impaired renal function (estimated glomerular filtration rate < 30ml/min/1.73 m2) or receiving dialysis 7. History of abnormal bleeding and/or coagulopathy 8. 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 hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure 9. Active or suspected acute or chronic uncontrolled infection 10. History of intracranial hemorrhage 11. Cerebrovascular disease (multiple CVA or CVA within 6 months) 12. 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.) 13. Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema) 14. Untreated, uncontrolled sleep apnea 15. Are participating or have participated in another clinical trial in the last 30 days 16. Patients unable to communicate with the investigator and staff. 17. Presence of any other neurodegenerative disease like parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease. The presence of some mild parkinsonian features will be accepted since ET is recognized to be associated with overlap symptoms of PD. The mild PD symptoms that will be tolerated for inclusion into the trial include resting tremor, bradykinesia, and rigidity. 18. Presence of significant cognitive impairment as determined with a score = 24 on the Mini Mental Status Examination (MMSE) 19. History of immunocompromise, including patient who is HIV positive 20. Known life-threatening systemic disease 21. Patients with a history of seizures within the past year 22. Patients with psychiatric illness that are not well controlled. Any presence of psychosis will be excluded. Patients with mood disorders including depression will be excluded if they have exhibited symptoms within 6 months while on medication. Patients who have been treated with transcranial magnetic stimulation or ECT will be excluded. 23. Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter, PT > 14, PTT > 36 or INR > 1.3) or a documented coagulopathy 24. Patients with brain tumors 25. Any illness that in the investigator's opinion preclude participation in this study. 26. Pregnancy or lactation. 27. Legal incapacity or limited legal capacity. 28. Patients who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
InSightec |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of Thalamotomy lesion | Comparison of the stereotactic coordinates of the atlas to the lesion created in the brain. | 1 day | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT05381688 -
VIM DBS Respiratory Modulation: N-of-1 Trial
|
||
Recruiting |
NCT05101161 -
Neurofeedback Using Implanted Deep Brain Stimulation Electrodes
|
N/A | |
Completed |
NCT02277106 -
Evaluate SAGE-547 in Participants With Essential Tremor
|
Phase 2 | |
Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
Terminated |
NCT02678429 -
Atlas Predicted DBS Settings in Essential Tremor
|
N/A | |
Terminated |
NCT02894567 -
Evaluation of Directional Recording and Stimulation Using spiderSTN
|
N/A | |
Completed |
NCT02523807 -
Tremor Monitoring Device
|
N/A | |
Active, not recruiting |
NCT02255929 -
Gamma Knife Radiosurgery for Treatment of Essential Tremor
|
N/A | |
Completed |
NCT01223144 -
Decision-making and Emotion Recognition in Essential Tremor
|
N/A | |
Completed |
NCT00906412 -
Ventrointermediate Nucleus (VIM DBS) and Working Memory
|
N/A | |
Recruiting |
NCT05214222 -
Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT03051178 -
Wearable Sensor for Responsive DBS for ET
|
N/A | |
Recruiting |
NCT03795935 -
Relief From Side Effects: Clinical Use of Electrodes With Direction
|
N/A | |
Not yet recruiting |
NCT06036368 -
Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
|
N/A | |
Recruiting |
NCT05897775 -
Coordinated Reset Deep Brain Stimulation for Essential Tremor
|
Phase 1 | |
Recruiting |
NCT05968976 -
Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET
|
N/A | |
Completed |
NCT06314139 -
Tolerability and Efficacy of Continuous Theta-burst Stimulation for Essential Tremor: A Randomized Study.
|
N/A | |
Recruiting |
NCT04501133 -
Sensory-specific Peripheral Stimulation for Tremor Management
|
N/A | |
Active, not recruiting |
NCT03560622 -
Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy
|
N/A | |
Completed |
NCT00368199 -
Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes
|
N/A |