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

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ClinicalTrials.gov Identifier: NCT03305588
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Markus Bredel, University of Alabama at Birmingham

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).

Condition or disease Intervention/treatment Phase
Essential Tremor Parkinson Disease Device: Unframed Virtual Cone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RAD 1601: Pilot Trial of Frameless Virtual Cone Stereotactic Radiosurgical Thalamotomy for Intractable Tremor and Advanced Functional Connectivity Parcellation of the Thalamus
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 130 Gy Radiation & Unframed Virtual Cone
130 Gy Virtual Cone Radiosurgery Unframed (Face Mask)
Device: Unframed Virtual Cone
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.




Primary Outcome Measures :
  1. Overall tremor reduction proportion evaluated by the Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) [ Time Frame: From Baseline up to 1 Year following completion of radiosurgery ]
    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.


Secondary Outcome Measures :
  1. Number of Participants with treatment-related adverse events [ Time Frame: From Baseline up to 1 Year following completion of radiosurgery ]
    Based on the assessments of the patient and the responses provided by the patient in questionnaires, the investigators will assess acute and late neurologic toxicities. All adverse events/toxicities will be assessed with the utilization of CTCAE v.4.0.

  2. Changes in resting-state functional MRI (fMRI) and diffusion tensor patterns associated with Radiosurgical thalamotomy [ Time Frame: From Baseline up to 1 Year following completion of radiosurgery ]
    Changes will be assessed by resting-state functional MRI (fMRI) to see the impact of radiosurgery ablation on brain function or alteration of function of the ventral intermediate nucleus of the thalamus.

  3. Mean of Quality of Life Scores measured by SF-36 questionnaire [ Time Frame: From Baseline up to 1 Year following completion of radiosurgery ]
    Quality of Life (QOL) will be measured by SF-36 questionnaire. This questionnaire consists of 36 questions (items) measuring physical and mental health in relation to 8 health concepts: physical functioning, bodily pain, role of limitations due to physical health problems, role of limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perception. All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively.

  4. Mean of Quality of Life Scores measured by PROMIS Upper Extremity Questionnaire [ Time Frame: From Baseline up to 1 Year following completion of radiosurgery ]
    PROMIS Upper Extremity questionnaire will assess effect of tremor on one's physical function of upper extremity, as well as, effects on activities of daily living.

  5. Patient Satisfaction Scores [ Time Frame: 3 Month Follow-Up Visit ]
    3 months following the completion of radiosurgery, the patient will be asked the following two questions: 1) Would the participant have the radiosurgery procedure again? 2) Would the participant recommend it to friends and family?

  6. Define Targeting Methods within Thalamus based on Structural and Functional Connectivity [ Time Frame: From Baseline up to 1 Year following completion of radiosurgery ]
    Compare how well the standard MRI conventional thalamotomy targeting technique (based on predetermined atlas coordinates) matches with advanced MRI-based (functional and structural) mapping of the thalamotomy target.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305588


Contacts
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Contact: Laronica Conway (205) 975-4362 laronicaconway@uabmc.edu
Contact: Kristin Webb kkwebb@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center Recruiting
Birmingham, Alabama, United States, 35249
Principal Investigator: Markus Bredel, MD, PhD         
Sub-Investigator: Harrison Walker, MD         
Sub-Investigator: Barton Guthrie, MD         
Sub-Investigator: Frank Skidmore, MD         
Sub-Investigator: Erik Middlebrooks, MD         
Sub-Investigator: John Fiveash, MD         
Sub-Investigator: Evan Thomas, MD, PhD         
Sub-Investigator: Asim Bag, MD         
Sub-Investigator: Victor Sung, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Markus Bredel, MD, PhD University of Alabama at Birmingham

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Responsible Party: Markus Bredel, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03305588     History of Changes
Other Study ID Numbers: IRB-160811009
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Markus Bredel, University of Alabama at Birmingham:
essential tremor (ET)
stereotactic radiosurgery (SRS)
radiosurgery (RS)
deep brain stimulation (DBS)
Parkinson's Disease (PD)
tremor-dominant Parkinson's disease (TDPD)

Additional relevant MeSH terms:
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Parkinson Disease
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms