Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease | Device: ExAblate Neuro Thalamotomy Treatment | Not Applicable |
The goal of this prospective, single-arm, multi-site, feasibility study is to develop data to evaluate the safety and effectiveness of unilateral focused ultrasound thalamotomy using this ExAblate Transcranial System in the treatment of medication-refractory tremor resulting from idiopathic Parkinson's disease.
The Indications for Use claim for this system is: treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | ExAblate Neuro Treatment Group |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease |
Actual Study Start Date : | February 6, 2017 |
Estimated Primary Completion Date : | August 30, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
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Experimental: ExAblate MRgFUS treatment
Ablation of Thalamus Vim nucleus with ExAblate 4000 Neuro MRgFUS for TDPD
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Device: ExAblate Neuro Thalamotomy Treatment
Non-invasive Focused Ultrasound Ablation of Thalamus Vim nucleus using ExAblate MRgFUS system for treatment Tremor Dominant Parkinson Disease
Other Names:
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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All subjects included in this study will have a TD/PIGD ratio > 1.15 in the medicated [ON] state as calculated from the UPDRS formula as described by S, et. al., [74].
Note: Ratios for TD/PIGD that are greater than or equal to 1.15 are defined as TDPD. PIGD includes those with a ratio of less than or equal to 0.9. Scores of greater than 0.9 and less than 1.15 are considered a mixed subtype.
Exclusion Criteria:
Subjects with unstable cardiac status including:
Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within the preceding 12 month period:
Subjects who have an Overall Skull Density Ratio of 0.30 (±0.05) or less as calculated from the screening CT.
Contact: Maritn Bernstein | +97248131268 | martinb@insightec.com |
China, Henan | |
Henan Provincial Peoples Hospital | Recruiting |
Zhengzhou, Henan, China | |
Contact: Yan Bai, MD +86-18838277756 zhaodedao@sina.com | |
Principal Investigator: Meiyun Wang, Prof. | |
Japan | |
Shonan Fujisawa Tokushukai Hospital | Recruiting |
Fujisawa, Kanagawa, Japan | |
Contact: Etsuko Shimizu +81-466-35-1177 shimizu@mirai-iryo.com | |
Principal Investigator: Tetsumasa Kamei, MD | |
Sub-Investigator: Hisashi Ito, MD | |
Sub-Investigator: Shigeru Fukutake, MD | |
Sub-Investigator: Kazuaki Yamamoto, MD |
Study Director: | Martin Bernstein | InSightec |
Tracking Information | |||||||
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First Submitted Date ICMJE | January 7, 2019 | ||||||
First Posted Date ICMJE | June 28, 2019 | ||||||
Last Update Posted Date | June 28, 2019 | ||||||
Actual Study Start Date ICMJE | February 6, 2017 | ||||||
Estimated Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Safety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease | ||||||
Official Title ICMJE | A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease | ||||||
Brief Summary | Safety and Effectiveness in ExAblate Neuro treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease. | ||||||
Detailed Description |
The goal of this prospective, single-arm, multi-site, feasibility study is to develop data to evaluate the safety and effectiveness of unilateral focused ultrasound thalamotomy using this ExAblate Transcranial System in the treatment of medication-refractory tremor resulting from idiopathic Parkinson's disease. The Indications for Use claim for this system is: treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: ExAblate Neuro Treatment Group Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Parkinson Disease | ||||||
Intervention ICMJE | Device: ExAblate Neuro Thalamotomy Treatment
Non-invasive Focused Ultrasound Ablation of Thalamus Vim nucleus using ExAblate MRgFUS system for treatment Tremor Dominant Parkinson Disease
Other Names:
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Study Arms ICMJE | Experimental: ExAblate MRgFUS treatment
Ablation of Thalamus Vim nucleus with ExAblate 4000 Neuro MRgFUS for TDPD
Intervention: Device: ExAblate Neuro Thalamotomy Treatment
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
50 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 31, 2020 | ||||||
Estimated Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | China, Japan | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04002596 | ||||||
Other Study ID Numbers ICMJE | PD001J | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | InSightec | ||||||
Study Sponsor ICMJE | InSightec | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | InSightec | ||||||
Verification Date | June 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |