Using stereotactic radiosurgery to treat malignant spasticity and hypertonia
Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia: a Pilot Study
This study is testing whether a special type of targeted radiation therapy can help people with severe spasticity who haven't found relief from regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Negrar, Verona) |
| Trial ID | NCT06309810 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of stereotactic radiotherapy in reducing symptomatic spasticity in patients with malignant spasticity. The study will enroll approximately 10 patients over a 24-month period, administering a single session of radiotherapy with a prescribed dose between 45 and 60 Gy. Patients will be monitored for one year post-treatment to assess improvements in posture and quality of life. The study focuses on patients who have not responded to conventional treatments for spasticity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe spasticity or hypertonia that has not responded to previous treatments.
Not a fit: Patients under 18 years old or those who have previously received radiation in the same anatomical site may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from malignant spasticity.
How similar studies have performed: While this approach is experimental, similar studies using stereotactic radiosurgery for other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Negrar, Verona
- IRCCS Sacro Cuore Don Calabria di Negrar — Negrar, Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Elvia Malo
- Email: ricerca.clinica@sacrocuore.it
- Phone: +390456014854
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.