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Radiation

Radiosurgery for Essential Tremor

N/A
Waitlist Available
Led By Markus Bredel, MD, PhD
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

Summary

This trial is testing a new treatment for tremor that is not responding to other treatments. The new treatment is a frameless Virtual Cone Radiosurgical Thalamotomy and the trial will use the Fahn-Tolosa-Marin Tremor Rating Scale to measure efficacy.

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).Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tremor
Secondary outcome measures
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: 130 Gy Radiation & Unframed Virtual ConeExperimental Treatment1 Intervention
130 Gy Virtual Cone Radiosurgery Unframed (Face Mask)

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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,880 Total Patients Enrolled
Markus Bredel, MD, PhDPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham

Media Library

Unframed Virtual Cone (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03305588 — N/A
Essential Tremor Research Study Groups: 130 Gy Radiation & Unframed Virtual Cone
Essential Tremor Clinical Trial 2023: Unframed Virtual Cone Highlights & Side Effects. Trial Name: NCT03305588 — N/A
Unframed Virtual Cone (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03305588 — N/A
~2 spots leftby Dec 2024