Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia

Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia: a Pilot Study

This is a pilot, experimental, monocentric study. The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity.

The study foresees the enrollment of about 10 patients, in a period of 24 months. The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 Gy; subsequently the patients will be followed up for one year.

Study Overview

• Status: Recruiting
• Conditions: Spasticity/Paresis
• Intervention / Treatment: Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvia Malo; Phone Number: +390456014854; Email: ricerca.clinica@sacrocuore.it

Study Locations

• Italy
  • Verona
    • Negrar, Verona, Italy, 37024
      • Recruiting
      • IRCCS Sacro Cuore Don Calabria di Negrar
      • Contact: Luca Nicosia, Doctor; Phone Number: +39(0)456014800; Email: luca.nicosia@sacrocuore.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Malignant spasticity measured with the Modified Ashworth Scale (MAS≥3) or highly impairing spasticity and hypertonia (Numeric Rating Scale >8 scored by patient or care-giver)
• Age ≥ 18 years old
• Availability of a diagnostic MR scan of the spine segment of interest and electromyography of inferior limbs within 3 months prior to study entry
• Previous ineffective conventional treatment for spasticity or absence of others therapeutic strategies (i.e. negative baclofen pump test, comorbidity limiting the pump implant as spondylodiscitis or severe obesity)
• Plegic patients or minimally conscious state patient
• Signed informed consent (in case of minimally conscious state patients, consent form will be signed by her / his legal representative)

Exclusion Criteria:

• Age < 18 years old
• Previous radiation in the same anatomical site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiotherapy; The treatment will be administered with a TrueBeam™ (Varian Medical Systems, Palo Alto, CA, USA) linac, equipped with a Millenium 120-leaves MLC. The target will be represented by 5 mm of the specific spinal nerve responsible for the spams. A lateral 1 mm margin will be added to the target to generate the corresponding planning treatment volume (PTV). The prescribed dose will be 45-60 Gy in a single fraction. The treatment dose will be chosen based on patients' general condition, and possibility to respect the dose limits (constraints) for the organs at risk (OARs).

Radiation: Radiotherapy; The treatment will be administered with a TrueBeam™ (Varian Medical Systems, Palo Alto, CA, USA) linac, equipped with a Millenium 120-leaves MLC. The target will be represented by 5 mm of the specific spinal nerve responsible for the spams. A lateral 1 mm margin will be added to the target to generate the corresponding planning treatment volume (PTV). The prescribed dose will be 45-60 Gy in a single fraction. The treatment dose will be chosen based on patients' general condition, and possibility to respect the dose limits (constraints) for the organs at risk (OARs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAS	Reduction of Modified Ashworth Scale (MAS) after SRS. A reduction of at least 1 point is considered for response evaluation.	1 year after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute and late toxicity (CTCAE)	Acute and late toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). More specifically, acute toxicity will be defined as any event occurred within 90 days from the RT treatment while late toxicity will be defined as any event recorded after this time.	90 days from the RT treatment
Quality of life (SF-12)	SF-12® Questionnaire will be administered to evaluate quality of life previously and after treatment (not applicable for patients in minimally conscious state).	1 year after treatment
Quality of nursing (VAS)	Visual Analogic Scale (VAS will be administered to the care-giver in minimally conscious state patient (VAS 1: many difficulties in nursing, VAS 10: none difficulties in nursing) before and after treatment.	1 year after treatment
Radiological characteristics and treatment-related changes of the spinal roots	The radiological characteristics and treatment-related changes of the spinal roots will be evaluated with multiparametric MR. Specific quantitative analyzed parameter will be: fractional anisotropy and diffusivity. Changes in morphology will be evaluated with a MR scan acquired 6 months after SRS.	6 months after SRS

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Paresis
• Other Study ID Numbers: 2022-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No