Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia
- Conditions
- Spasticity/Paresis
- Interventions
- Radiation: Radiotherapy
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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)
- Age < 18 years old
- Previous radiation in the same anatomical site
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiotherapy 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).
- 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