Deep Brain Frameless Radiosurgery for Drug Resistant Invalidating Tremor. Dose Escalation Pilot Study

NCT02585583 | Completed

• 1 other identifier: PR DB RS2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The gamma knife radiosurgical thalamotomy to treat many movement disorders is recently becoming a new and well defined treatment paradigm. The CyberKnife if compared to the frame-based radiosurgery, is a pain free procedure which offers the advantage of a better patient's compliance by avoiding local anaesthesia and the discomfort due to wearing the frame for the period of time needed for the whole procedure. Unfortunately the subtle but substantial differences about the 3D dose distribution and the dose fall-off features between GK and CK made mandatory investigations about the effectiveness and the safety when the cyberknife is used. Particularly the minimum effective and safety dose have to be defined yet A previous study (NCT02095600) failed in demonstrating the efficacy of 75 Gy, 80 Gy, 90 Gy. The aim of the present study is to investigate about the effectiveness of 100 Gy, 120 Gy, 130 Gy and 140 Gy. The safety and the targeting methodology will be also in investigated.

Conditions

Tremor, Limb

Keywords

Deep Brain; Essential tremor; Parkinson Disease; Tremor; Radiosurgery; Thalamotomy; deep brain stimulation; DBS; intractable, drug resistant, invalidating tremor

Outcome Measures

Primary Outcomes (1)

• Minimun effective dose (presence/absence of visible MRI thalamotomy)

  The aim of this study is to define the minimum effective dose to obtain a tremor control

  18 months

Secondary Outcomes (2)

• Targeting validation (post treatment thalamotomy merge the target plan)

  18 months

• Toxicity (according to NCI CTCAE v4.0)

  24 months

Study Arms (1)

Radiosurgical thalamotomy

OTHER

Patients will undergo to radiosurgical thalamotomy by Cyberknife system.

Radiation: Thalamotomy

Interventions

Thalamotomy RADIATION

VoA-Vop complex of the thalamous or VIM nucleus will be targeted. 100 Gy, 120 Gy, 130 Gy, 140 Gy will be the foreseen prescription dose. CyberKnife will be always used to perform the procedure.

Radiosurgical thalamotomy

Eligibility Criteria

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

You may qualify if:

• Patients affected by severe upper limb tremor refractory to medical therapy and who are less than optimal candidate for a deep brain stimulation (DBS) procedure.
• Age ≥ 18 years old
• Refusal of DBS procedure
• Written consent

You may not qualify if:

• Pregnancy
• CT/MRI contraindication
• Illiteracy

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Radiotherapy Unit

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Tremor; Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Marcello Marchetti, MD

  Fondazione Irccs Istituto Neurologico Carlo Besta

  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: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 23, 2015
• Study Start: May 1, 2015
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 8, 2024

Record last verified: 2020-02

Locations

IT (1)