Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia

NCT06309810 | Recruiting

• 1 other identifier: 2022-35
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity/Paresis

Outcome Measures

Primary Outcomes (1)

• MAS

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

  1 year after treatment

Secondary Outcomes (4)

• Acute and late toxicity (CTCAE)

  90 days from the RT treatment

• Quality of life (SF-12)

  1 year after treatment

• Quality of nursing (VAS)

  1 year after treatment

• Radiological characteristics and treatment-related changes of the spinal roots

  6 months after SRS

Study Arms (1)

Radiotherapy

EXPERIMENTAL

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).

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

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).

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Age \< 18 years old
• Previous radiation in the same anatomical site

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, 37024, Italy

RECRUITING

MeSH Terms

Conditions

Muscle Spasticity; Paresis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Elvia Malo

CONTACT

+390456014854; ricerca.clinica@sacrocuore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: March 13, 2024
• Study Start: March 6, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

IT (1)