Clinical Trials Logo
  1. Home
  2. Essential Tremor
  3. NCT01932463

ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) for Treatment of Tremor

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

Clinical Trial Summary

A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor

Clinical Trial Description

The non-invasive high-intensity focused ultrasound has been coupled with high resolution MRI to provide precise, consistent treatments that can be monitored in real-time. The development of phased array transducers allows for tightly focused treatment volumes and for the ability to compensate for distortions by tissue inhomogeneities. The landmark advance in MRgFUS for neurosurgeons occurred as the ability to sonicate through the intact cranium was achieved with phased array transducers and acoustic modeling using CT reconstructions of the skull. By coupling HIFU with MRI, detailed treatment plans can be generated and intra-procedure real-time monitoring is available. Standard MR sequences have been shown to reliably predict tissue damage during thermal lesioning with ultrasound. The precision of the technology has already been demonstrated in animal models and is currently being investigated in humans with brain tumors and neuropathic pain syndromes. Unlike stereotactic radiosurgery, the treatment can be monitored continuously in real time with MRI and MR-thermography. We anticipate that a MRgFUS non-invasive thermal lesioning is similarly as safe as DBS (or other current procedure and will provide several years of benefit through reduction of contralateral motor symptoms and potential medication side effects in ET, while still permitting subsequent treatment with DBS should that become clinically desirable. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01932463
Study type Interventional
Source InSightec
Contact
Status Completed
Phase N/A
Start date May 2011
Completion date July 2013
View Details
See also
  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Withdrawn NCT05381688 - VIM DBS Respiratory Modulation: N-of-1 Trial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