Active — Not RecruitingNot Applicable

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

United States40 participantsStarted 2017-12-05

Plain-language 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 Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) in patients who are not candidates for deep brain stimulation (DBS).

Who can participate

Age range18 Years – 99 Years

SexALL

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

What they're measuring

Overall tremor reduction proportion evaluated by the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS)

Timeframe: From Baseline up to 36 months following completion of radiosurgery

Trial details

NCT IDNCT03305588

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

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