Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia

Not Applicable

Recruiting

• Conditions: Spasticity/Paresis

• Registration Number: NCT06309810
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-06
• Study First Submitted: 2023-06-20
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Acute and late toxicity (CTCAE)	90 days from the RT treatment	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.
Quality of life (SF-12)	1 year after treatment	SF-12® Questionnaire will be administered to evaluate quality of life previously and after treatment (not applicable for patients in minimally conscious state).
Radiological characteristics and treatment-related changes of the spinal roots	6 months after SRS	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.
Quality of nursing (VAS)	1 year after treatment	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.

Trial Locations

Locations (1)

IRCCS Sacro Cuore Don Calabria di Negrar; 🇮🇹 Negrar, Verona, Italy