Status:

ACTIVE_NOT_RECRUITING

RAD 1601: EDGE Radiosurgery for Intractable Essential Tremor and Tremor-Dominant Parkinson's Disease

Lead Sponsor:

University of Alabama at Birmingham

Conditions:

Essential Tremor

Parkinson Disease

Eligibility:

All Genders

18-99 years

Phase:

NA

Brief Summary

To determine the efficacy of frameless Virtual Cone Radiosurgical Thalamotomy for medically refractory tremor resulting from either Essential Tremor or Tremor-Dominant Parkinson's Disease with the Fah...

Detailed Description

Per the National Institute of Neurological Disorders and Stroke, tremor is an involuntary, rhythmic muscle contraction leading to shaking movements in one or more parts of the body. It is a common mov...

Eligibility Criteria

Inclusion

  • Patients with medical refractory essential tremor or tremor-dominant Parkinson's disease that are not candidates for deep brain stimulation (DBS), either by medical/surgical co-morbidities or by choice.
  • Patients must have an ECOG status of 0, 1, or 2.
  • Patients must be at least 18 years of age.
  • All patients must be given written informed consent.

Exclusion

  • Patients who have had prior radiosurgery or therapeutic brain radiation therapy.
  • Patients with medical contra-indications to MRI imaging (e.g. pacemaker).

Key Trial Info

Start Date :

December 5 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03305588

Start Date

December 5 2017

End Date

February 1 2026

Last Update

October 15 2025

Active Locations (1)

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University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, United States, 35249