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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment for individuals with severe tremors caused by Essential Tremor or Tremor-Dominant Parkinson's Disease, particularly when other treatments like deep brain stimulation are not viable. The researchers are using a special type of radiosurgery called the Unframed Virtual Cone to determine its effectiveness in reducing tremors. Participants should be adults who have not undergone prior brain radiation treatment and who cannot or choose not to have deep brain stimulation. Those with a medical condition that prevents MRI use should not participate in this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that might not yet be widely available.

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 prior data suggests that this radiosurgery technique is safe for treating tremors?

Research has shown that frameless Virtual Cone radiosurgery is generally safe and well-tolerated. In a study with 42 patients, doctors carefully examined the brain after treatment and monitored tremor symptoms and quality of life. The results indicated that patients experienced very few negative side effects.

Another source highlights that this treatment is noninvasive, meaning it doesn't involve surgery, and it is frameless, so it doesn't require a head frame. This potentially makes it less risky and more comfortable for patients compared to other types of radiosurgery.

Overall, evidence suggests that this treatment is generally safe, with few side effects reported in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for essential tremor, which typically involve medications like beta-blockers or anticonvulsants, the Unframed Virtual Cone radiosurgery offers a non-invasive approach. This technique uses a precise delivery of 130 Gy radiation targeting specific brain areas responsible for tremors, potentially offering relief without the side effects associated with drugs. Researchers are excited because this method could provide a safer alternative with fewer complications, improving the quality of life for patients who don't respond well to conventional therapies.

What evidence suggests that this radiosurgery technique is effective for essential tremor?

Research has shown that frameless radiosurgery, such as the Unframed Virtual Cone treatment provided in this trial, effectively reduces tremors in individuals with essential tremor. This method uses focused radiation to disrupt the brain signals causing tremors, resulting in significant symptom relief. Studies indicate that patients experience a noticeable decrease in tremor severity following this treatment. For those unable to undergo deep brain stimulation, this presents a promising alternative. While additional information is beneficial, early evidence suggests this technique could reliably manage tremors. ^{1 2 3 5 6}

Who Is on the Research Team?

John B. Fiveash

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-essential-tremor-11-2017-1d519

Radiosurgery for Essential Tremor · Info for Participants Research shows that frameless radiosurgery, which is similar to the Unframed Virtual Cone treatment, can effectively reduce tremors in patients with essential ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03305588

RAD 1601: EDGE Radiosurgery for Intractable Essential ... To determine the efficacy of frameless Virtual Cone Radiosurgical Thalamotomy for medically refractory tremor resulting from either Essential Tremor or Tremor- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6127970/

The virtual cone: A novel technique to generate spherical ... The purpose of the trial is to determine the feasibility of frameless trigeminal neuralgia radiation surgery using the virtual cone and to measure pain relief ...

4. researchgate.net researchgate.net/publication/323529794_The_virtual_cone_a_novel_technique_to_generate_spherical_dose_distributions_using_a_multi-leaf_collimator_and_standardized_control-point_sequence_for_small_target_radiosurgery

The virtual cone: a novel technique to generate spherical ... The virtual cone: a novel technique to generate spherical dose distributions using a multi-leaf collimator and standardized control-point ...

5. nsaneurosurgeons.com nsaneurosurgeons.com/wp-content/uploads/2019/05/Thomas_Functional-Neurosurgical-Applications-of-Modern-Precision-Radiosurgery_web.pdf

5/29/2019 1 130 Gy Virtual Cone. Unilateral thalamic ventral ... Determine the efficacy of frameless Virtual Cone SRS thalamotomy in tremor patients.

6. redjournal.org redjournal.org/article/S0360-3016(23)05074-5/abstract

Frameless LINAC-Based Stereotactic Radiosurgery is Safe ... We surveilled post-treatment imaging and recorded tremor scoring, QOL outcomes, and adverse events. Results. We accrued 42 patients (16 female, ...