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2022H0425

Radiosurgery treatment for spasticity associated with stroke, sci & cerebral palsy
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT06070233
Spasticity as Sequela of Stroke
Spastic Cerebral Palsy
Spasticity, Muscle

Population cible

Condition médicale (spécialité visée)

Choix aire thérapeutique

Spasticity as Sequela of Stroke

Spastic Cerebral Palsy

Spasticity, Muscle

Source : Importé depuis le centre

Profil des participants

Sexe(s) des participants

All

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots
Age > 16 (if under 18, patients parents must sign consent).

Exclusion Criteria:

Inability to lie supine for simulation & treatment
Inability to visualize the target nerve on either CT or MRI imaging
Patients with confirmed pregnancy (all women of child-bearing age with intact uterus & ovaries will be required to undergo a pregnancy test prior to simulation)

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Sham Treatment Donnée non disponible No intervention but can crossover after 6 months
  • Inconnu
  • SRS Treatment Donnée non disponible Donnée non disponible
  • Inconnu
  • Sham Treatment
    État du recrutement
    unknown
    SRS Treatment
    État du recrutement
    unknown
    Données à jour depuis : 2 avril 2024

    Description de l'étude

    Résumé de l'étude

    A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.

    Source : Importé depuis le centre

    Sites

    Centres participants

      2 centres
    • CENTRO DIAGNOSTICO ITALIANO

      Milano

      ITALY

      Recrutement local
      État du recrutement: OUVERT
      Coordonnées pour le recrutement
      Contacts locaux
      chercheurs:
    • THE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER ( SITE 1032)

      Columbus

      OHIO, UNITED STATES

      Recrutement local
      État du recrutement: OUVERT
      Coordonnées pour le recrutement
      Contacts locaux
      chercheurs:

    Dernière modification : 2 avril 2024
    Données à jour depuis : 4 avr.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT06070233