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Stereotaxic effect in non-malignant diseases.

Therapeutic use of stereotactic body radiotherapy (SBRT) in the management of patients with malignant spasticity.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240827062885N1
Enrollment
10
Registered
2024-09-23
Start date
2024-12-10
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant spasticity. Other symptoms and signs involving the nervous and musculoskeletal systems

Interventions

Intervention group: Patients with malignant spasticity unresponsive to previous treatment..

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Malignant spasticity measured with the Modified Ashworth Scale (MAS=?/ highly impairing spasticity with Numeric Rating Scale >?). Age = ?? years old. Previous ineffective conventional treatment for spasticity. Absence of others therapeutic strategies (i.e. negative baclofen pump test, comorbidity)limiting the pump implant as spondylodiscitis or severe obesity. Signed informed consent.

Exclusion criteria

Exclusion criteria: Previous radiation in the same anatomical site.

Design outcomes

Primary

MeasureTime frame
Quality of life. Timepoint: Previously and after treatment. Method of measurement: Quality of life scale.;Modified Ashworth Scale. Timepoint: MAS will be evaluated at 1, 3, 6, and 12 months after SRS. Method of measurement: Examination.;Acute and late toxicity. Timepoint: 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. Method of measurement: Questionnaire CTCAE (version 5.0).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Jafari

Tehran University of Medical Sciences

Jafari-f@razi.tums.ac.ir+98 21 6119 2585

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026