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

NCT03305588 | Active Not Recruiting FDA Device

• 2 other identifiers: IRB-160811009Siemans
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Essential Tremor; Parkinson Disease

Keywords

essential tremor (ET); stereotactic radiosurgery (SRS); radiosurgery (RS); deep brain stimulation (DBS); Parkinson's Disease (PD); tremor-dominant Parkinson's disease (TDPD)

Outcome Measures

Primary Outcomes (1)

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

  The Fahn-Tolosa-Marin Tremor Rating Scale evaluation will assess the severity of the patient's tremor and measure the impact on their activities of daily living.

  From Baseline up to 36 months following completion of radiosurgery

Secondary Outcomes (7)

• Number of Participants with treatment-related adverse events

  From Baseline up to 36 months following completion of radiosurgery

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

  From Baseline up to 36 months following completion of radiosurgery

• Mean of Quality of Life Scores measured by SF-36 questionnaire

  From Baseline up to 36 months following completion of radiosurgery

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

  From Baseline up to 36 months following completion of radiosurgery

• Patient Satisfaction Scores

  3 Month Follow-Up Visit

Study Arms (1)

130 Gy Radiation & Unframed Virtual Cone

EXPERIMENTAL

130 Gy Virtual Cone Radiosurgery Unframed (Face Mask)

Device: Unframed Virtual Cone

Interventions

Unframed Virtual Cone DEVICE

The patient will undergo stereotactic radiosurgery. Radiosurgery is a single non-surgical radiation treatment and will be done as an outpatient procedure. High-energy radiation will be delivered to a small, precise area of the patient's brain using a linear accelerator. A face mask (unframed) will be placed over the patient's face to keep their head from moving during the procedure. During the procedure, the study doctor will confirm the exact location that needs to be treated using x-rays and optical imaging cameras. The face mask will hold the patient's head to prevent it from moving and to focus the x-rays and aim them on a small area in the thalamus of the patient's brain. For most patients, the actual time on the radiosurgery treatment machine is 30 to 60 minutes. The face mask will be removed after the treatment.

130 Gy Radiation & Unframed Virtual Cone

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

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

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

• Middlebrooks EH, Popple RA, Greco E, Okromelidze L, Walker HC, Lakhani DA, Anderson AR, Thomas EM, Deshpande HD, McCullough BA, Stover NP, Sung VW, Nicholas AP, Standaert DG, Yacoubian T, Dean MN, Roper JA, Grewal SS, Holland MT, Bentley JN, Guthrie BL, Bredel M. Connectomic Basis for Tremor Control in Stereotactic Radiosurgical Thalamotomy. AJNR Am J Neuroradiol. 2023 Feb;44(2):157-164. doi: 10.3174/ajnr.A7778. Epub 2023 Jan 26.

  PMID: 36702499 DERIVED

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• John Fiveash, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 10, 2017
• Study Start: December 5, 2017
• Primary Completion: October 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)