At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Unilateral thalamotomy (device)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Unilateral thalamotomy — device: Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
- Patient visit burden
- Not specified by the sponsor
In plain English
This registry study collects information from people with tremor-dominant Parkinson's disease (a brain condition causing shaking that medicine has not controlled) who are having a treatment called Exablate. Exablate is a procedure that treats one side of a part of the brain called the thalamus. The study is run after the treatment has already been approved, and is paid for by a company called InSightec.
Who can take part
- Men and women aged 30 or older
- You are already going to have an Exablate procedure as part of your usual care for tremor-dominant Parkinson's disease
- You are willing to follow the registry's requirements, including going to all study visits
- You have signed and received a copy of the consent form
Who may not be able to
- You do not agree to take part, or you are unlikely to stay in the study for its whole length
What taking part involves
- • Having the Exablate procedure as part of your planned treatment at your hospital
- • Taking part in study visits and following the registry's requirements
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and exactly what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 30 Years to 99 Years
- Who
- All
- Number of participants
- 50
- Started
- 2022-04-28
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for tremor associated with tremor dominant parkinson's disease
- • Clinical study - 50 participants
- • The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system
Who can take part?
- • Ages 30 Years to 99 Years
- • Diagnosed with tremor associated with tremor dominant parkinson's disease
Where?
- • Dundee - University of Dundee
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
More detail
This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD. The following assessments will be collected at Baseline,1, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years: * Adverse Events (AEs) (does not apply to Baseline Visit) * Medication usage * Clinical Rating Scale for Tremor (CRST) ON medication * Unified Parkinson's Disease Rating Scale Part III ON medication * EQ-5D-5L * WPAI-GH
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 30 Years - 99 Years
- Who can join: All genders
What the study is looking for
- ✓Men and women, age 30 years and older
- ✓Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution the usual treatment.
- ✓Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion...
- ✓Subject has signed and received a copy of the approved agreement to take part form
Who cannot take part
- ✗Subject does not agree to participate or is unlikely to participate for the entirety of the study.
See the full criteria
Where Is This Study? (1 UK site)
University of Dundee
Dundee DD1 9SY, United Kingdom
How to Get in Touch
Matt Hibert
Sponsor contactCONTACT