Spasticity/ParesisNCT06309810
Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia
A study testing Radiotherapy in people with Spasticity/Paresis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity/Paresis
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2023to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Age < 18 years old
- Previous radiation in the same anatomical site
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria di Negrar
Negrar, Verona, 37024
Luca Nicosia, Doctor, +39(0)456014800, luca.nicosia@sacrocuore.it
About this study
Official title: 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.
- Conditions
- Spasticity/Paresis
- Being tested
- Radiotherapy
- Medical subject headings
- Muscle Spasticity, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAS
Reduction of Modified Ashworth Scale (MAS) after SRS. A reduction of at least 1 point is considered for response evaluation.
Measured: 1 year after treatment
Secondary outcomes (4)
Acute and late toxicity (CTCAE)
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.
Measured: 90 days from the RT treatment
Quality of life (SF-12)
SF-12® Questionnaire will be administered to evaluate quality of life previously and after treatment (not applicable for patients in minimally conscious state).
Measured: 1 year after treatment
Quality of nursing (VAS)
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.
Measured: 1 year after treatment
Radiological characteristics and treatment-related changes of the spinal roots
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.
Measured: 6 months after SRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start6 Mar 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity/ParesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309810
- Sponsor's protocol ID
- 2022-35
- Status last verified
- Mar 2024
- First submitted
- 20 Jun 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia: a Pilot Study
- ClinicalTrials.gov ID
- NCT06309810
- Acronym / sponsor ID
- 2022-35
- Conditions
- Spasticity/Paresis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: RadiotherapyThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 18 years old
- Previous radiation in the same anatomical site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyThe 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 |
Primary outcome
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.
4 secondary outcomes
Acute and late toxicity (CTCAE)
Time frame: 90 days from the RT treatment
Quality of life (SF-12)
Time frame: 1 year after treatment
Quality of nursing (VAS)
Time frame: 1 year after treatment
Radiological characteristics and treatment-related changes of the spinal roots
Time frame: 6 months after SRS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with Spasticity/Paresis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo (+390456014854, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAS (time frame: 1 year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.