What side effects are associated with this type of intervention?

Common treatments for Essential Tremor, such as radiosurgical thalamotomy, can have several side effects. These include temporary or persistent gait disturbances, numbness, paresthesia, and in some cases, dysphagia and facial sensory loss. While these treatments are generally effective in reducing tremor severity, there is a risk of gradual loss of efficacy over time. Additionally, non-invasive neuromodulation techniques may cause lightheadedness, tingling, and tinnitus, but are generally considered safe with minimal adverse events.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments of Essential Tremor that are similar to the Frameless Virtual Cone Radiosurgical Thalamotomy. However, it does discuss various noninvasive and surgical options for medically refractory tremor, including Gamma Knife thalamotomy and other forms of stereotactic radiosurgery. These treatments involve targeted radiation to create lesions in the thalamus, aiming to reduce tremor severity in patients who are not candidates for deep brain stimulation.

What other types of research exist?

Promising, novel alternatives to Frameless Virtual Cone Radiosurgical Thalamotomy for Essential Tremor patients include Deep Brain Stimulation (DBS), which involves implanting electrodes in the brain to modulate neural activity, and MRI-guided Focused Ultrasound (MRgFUS), a non-invasive procedure that uses focused ultrasound waves to create precise lesions in the thalamus. Both options have shown significant efficacy in reducing tremor.

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Radiation

Radiosurgery for Essential Tremor

N/A

Waitlist Available

Led By John Fiveash, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be at least 18 years of age.

Patients must have an ECOG status of 0, 1, or 2.

Must not have

Patients who have had prior radiosurgery or therapeutic brain radiation therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 36 months following completion of radiosurgery

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

Potential side effects may include temporary swelling or permanent changes in a small part of the brain treated, which could affect other body functions controlled by that area. MRI scans are used, so risks associated with MRI also apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had brain radiation therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 36 months following completion of radiosurgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 36 months following completion of radiosurgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 36 months following completion of radiosurgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tremor

Secondary study objectives

Changes in resting-state functional MRI (fMRI) and diffusion tensor patterns associated with Radiosurgical thalamotomy

Thalamic structure

Mean of Quality of Life Scores measured by PROMIS Upper Extremity Questionnaire

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 130 Gy Radiation & Unframed Virtual ConeExperimental Treatment1 Intervention

130 Gy Virtual Cone Radiosurgery Unframed (Face Mask)

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Essential Tremor (ET) include neuromodulation and radiosurgical thalamotomy. Neuromodulation, such as noninvasive nerve stimulation, works by modulating abnormal neural activity to reduce tremor severity. Radiosurgical thalamotomy, like the frameless Virtual Cone Radiosurgical Thalamotomy, targets the ventral intermediate nucleus of the thalamus with precise radiation to create a lesion, disrupting the neural circuits responsible for tremor. This is particularly important for ET patients who are not candidates for deep brain stimulation (DBS) due to surgical risks, offering a non-invasive yet effective treatment option.

Radiotherapy of non-tumoral refractory neurological pathologies.Vim stereotactic radiosurgical thalamotomy for drug-resistant idiopathic Holmes tremor: a case report.Advances in diagnosis and treatment of trigeminal neuralgia.