Essential TremorNCT02289560
Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
A study testing Transcranial ExAblate in people with Essential Tremor, run by InSightec at 7 sites in United States.
Trial summary
The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Transcranial ExAblate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2015to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age 22 years and older
- Subjects who are able and willing to give informed consent and able to attend all study visits
- Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
- Subject exhibits a significant disability from their ET despite medical treatment
- Subjects should be on a stable dose of all ET medications for 30 days prior to study entry
- Subject is able to communicate sensations during the ExAblate Transcranial procedure
Who cannot join
- Subjects with unstable cardiac status
- Severe hypertension
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
- Significant claustrophobia that cannot be managed with mild medication
- Current medical condition resulting in abnormal bleeding and/or coagulopathy
Show all 14Show fewer
- 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
- History of intracranial hemorrhage
- History of multiple strokes, or a stroke within past 6 months
- Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- Are participating or have participated in another clinical trial in the last 30 days
- Subjects unable to communicate with the investigator and staff
- Subjects with a history of seizures within the past year
- Subjects with brain tumors
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Maryland Medical System
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Virginia
Charlottesville, Virginia, 22908
The Ohio State Wexner Medical Center
Columbus, Ohio, 43210
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Swedish Medical Center
Seattle, Washington, 98122
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Continued Access Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).
Read the detailed description
This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.
- Conditions
- Essential Tremor
- Being tested
- Transcranial ExAblate
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial ExAblateDevice
Also called ExAblate, TcMRgFUS, Thalamotomy
Transcranial ExAblate
| Study group | Role | What they receive |
|---|---|---|
| Transcranial ExAblate | Experimental | Transcranial ExAblate Receives: Device: Transcranial ExAblate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Device and Procedure Related Adverse Events.
The cumulative sum of adverse events was followed through Year 5 of the study.
Measured: 5 Years post treatment
Secondary outcomes (4)
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Scores Summed
Sum of baseline and follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and Follow Up were calculated at baseline and follow-up visits averaged across subjects. Low scores are better (show improvement).
Measured: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Clinical Rating Scale for Tremor (CRST Part A) Posture Score Change From Baseline
The Posture Score is a sub-Score of the Clinical Rating Scale for Tremor CRST Part A - Posture (Treated Side Upper Extremity Posture Score). The minimum-maximum average score range is 0-4 and higher scores indicate worse outcomes.
Measured: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Clinical Rating Scale for Tremor Part C - Activities of Daily Living.
Subject daily functionalities as measured by Clinical Rating Scale for Tremor Part C, CRST Part-C (subscales). CRST Part-C is an 8-item score with a minimum-maximum range of 0-32. Higher scores mean worse outcomes.
Measured: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Quality of Life in Essential Tremor Total (QUEST)
The QUEST Summary Total was used to assess quality of life changes over time in tremor patients. The QUEST consists of five dimensions for each subject converted to a percent of the total (0-100%). The summary total is the average of the five dimensions. Low Total scores are better.
Measured: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startApr 2015
- Primary completion18 Feb 2022
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289560
- Sponsor's protocol ID
- ET002CA
- Status last verified
- Jun 2024
- First submitted
- 10 Nov 2014
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Continued Access Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
- ClinicalTrials.gov ID
- NCT02289560
- Acronym / sponsor ID
- ET002CA
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).
Detailed description
This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial ExAblate | Experimental | Device: Transcranial ExAblateTranscranial ExAblate |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women, age 22 years and older
- Subjects who are able and willing to give informed consent and able to attend all study visits
- Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
- Subject exhibits a significant disability from their ET despite medical treatment
- Subjects should be on a stable dose of all ET medications for 30 days prior to study entry
Key exclusion criteria (14 listed)
- Subjects with unstable cardiac status
- Severe hypertension
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
- Significant claustrophobia that cannot be managed with mild medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial ExAblateAlso: ExAblate, TcMRgFUS, ThalamotomyTranscranial ExAblate | Device | Transcranial ExAblate |
Primary outcome
Number of Device and Procedure Related Adverse Events.
Time frame: 5 Years post treatment
The cumulative sum of adverse events was followed through Year 5 of the study.
4 secondary outcomes
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Scores Summed
Time frame: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Clinical Rating Scale for Tremor (CRST Part A) Posture Score Change From Baseline
Time frame: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Clinical Rating Scale for Tremor Part C - Activities of Daily Living.
Time frame: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Quality of Life in Essential Tremor Total (QUEST)
Time frame: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Essential Tremor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial ExAblate in people with Essential Tremor, run by InSightec at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Device and Procedure Related Adverse Events. (time frame: 5 Years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.