Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- MAS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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).
Intervention: Radiotherapy (Radiation)
Outcomes
Primary Outcomes
MAS
Time Frame: 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 Outcomes
- Acute and late toxicity (CTCAE)(90 days from the RT treatment)
- Quality of life (SF-12)(1 year after treatment)
- Radiological characteristics and treatment-related changes of the spinal roots(6 months after SRS)
- Quality of nursing (VAS)(1 year after treatment)