Radiosurgery for Essential Tremor

Overseen By Asim Bag, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Prior radiosurgery, Brain radiation, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Unframed Virtual Cone for essential tremor?

Research shows that frameless radiosurgery, which is similar to the Unframed Virtual Cone treatment, can effectively reduce tremors in patients with essential tremor and Parkinson's disease. Studies indicate that targeting the ventral intermediate nucleus of the thalamus with this noninvasive approach can lead to significant tremor improvement without added side effects. ^{1 2 3 4 5}

Is radiosurgery for essential tremor safe?

Radiosurgery for essential tremor, including techniques like gamma knife thalamotomy, is generally considered safe and well-tolerated. Most complications are mild and temporary, such as numbness or weakness, though rare severe complications like difficulty swallowing or death have been reported. ^{1 2 3 6 7}

How does the Unframed Virtual Cone treatment for essential tremor differ from other treatments?

The Unframed Virtual Cone treatment is a type of radiosurgery that is noninvasive and frameless, making it more accessible and potentially less risky than traditional frame-based methods. It targets the ventral intermediate nucleus of the thalamus, similar to other treatments like deep brain stimulation, but does so without the need for open surgery. ^{1 2 4 8 9}

What is the purpose of this trial?

This trial is testing a non-surgical radiation treatment to help people with severe tremors from Essential Tremor or Parkinson's Disease who can't have traditional brain surgery. The treatment aims to reduce shaking by targeting specific brain areas with precise radiation. This minimally invasive alternative to traditional brain surgery is designed for treating tremors in conditions like Essential Tremor and Parkinson's Disease.

Research Team

John B. Fiveash

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults with severe, treatment-resistant shaking (tremor) due to Essential Tremor or Parkinson's Disease who can't have deep brain stimulation because of health issues or personal choice. They should be able to perform daily activities with minimal assistance (ECOG status 0-2).

Inclusion Criteria

All patients must be given written informed consent.

I am able to care for myself and up and about more than 50% of my waking hours.

I have severe tremor from Parkinson's or essential tremor and cannot or choose not to have DBS surgery.

Exclusion Criteria

You cannot have an MRI because of a medical reason, such as having a pacemaker.

I have had brain radiation therapy before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 130 Gy Virtual Cone Radiosurgery Unframed (Face Mask)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Regular follow-up visits

Treatment Details

Interventions

• Unframed Virtual Cone

Trial Overview The study tests a non-invasive procedure called Virtual Cone Radiosurgical Thalamotomy, which targets the brain area causing tremors. It aims to reduce tremors in patients who haven't improved with medication and aren't suitable for surgery.

Participant Groups

Group I: 130 Gy Radiation & Unframed Virtual Cone Experimental Treatment 1 Intervention

130 Gy Virtual Cone Radiosurgery Unframed (Face Mask)

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

Gamma knife stereotactic radiosurgical thalamotomy is a safe and well-tolerated treatment option for patients with intractable tremor who have not responded to medical therapy and are not surgical candidates, based on a systematic review of available literature.

While complications can occur, they are generally mild and include issues like contralateral numbness and transient hemiparesis, with severe complications being rare; this suggests that the procedure has a favorable safety profile when using doses between 130 to 150 Gy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamma knife stereotactic radiosurgical thalamotomy for intractable tremor: a systematic review of the literature. Campbell, AM., Glover, J., Chiang, VL., et al.[2022]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Assessing the clinical outcome of Vim radiosurgery with voxel-based morphometry: visual areas are linked with tremor arrest! [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Thalamotomy for Refractory Tremor by Frameless Radiosurgery. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Metabolic Positron Emission Tomography Response to Gamma Knife of the Ventral Intermediate Nucleus in Essential Tremor. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Diffusion tractography imaging-guided frameless linear accelerator stereotactic radiosurgical thalamotomy for tremor: case report. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Margin of error for a frameless image guided radiosurgery system: Direct confirmation based on posttreatment MRI scans. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Gamma knife stereotactic radiosurgical thalamotomy for intractable tremor: a systematic review of the literature. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for tremor: systematic review. [2019]

8. Austria pubmed.ncbi.nlm.nih.gov

Deep brain stimulation and frameless stereotactic radiosurgery in the treatment of bilateral parkinsonian tremor: target selection and case report of two patients. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

Targeting for stereotactic radiosurgical thalamotomy based on tremor treatment response. [2023]