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.

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