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Lo studio clinico NCT07433023 per Paralisi cerebrale è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy Fase II 80 Randomizzato
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La sperimentazione clinica NCT07433023 è uno studio interventistico di Fase II volto a esaminare altro per Paralisi cerebrale, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 marzo 2026, con l'obiettivo di raggiungere 80 partecipanti. Sotto la guida di Shirley Ryan AbilityLab, dovrebbe concludersi entro il 1 gennaio 2029. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 febbraio 2026.
Sommario breve
This is an intervention study to investigate the impact of spinal stimulation on mobility outcomes in children with Cerebral Palsy. Participants will complete a 16-week training program with weekly sessions of spinal stimulation and walking or activity-based training. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the spinal...Mostra di più
Descrizione dettagliata
This project will investigate the impact of transcutaneous spinal cord stimulation (tSCS) on gait and activity-based training in children with Cerebral Palsy. Through a 1:1 randomization, a subset of participants will also receive a dose of 5-azacitidine (AZA), an FDA-approved drug for pediatric oncology, or a placebo. Research in muscle fibers as shown that AZA aids in muscle growth and regeneration. The use of AZA ...Mostra di più
Titolo ufficiale
Advancing Neurorehabilitation: Evaluating Transcutaneous Spinal Stimulation and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy
Patologie
Paralisi cerebraleAltri ID dello studio
- STU00225218
Numero NCT
Data di inizio (effettiva)
2026-03-01
Ultimo aggiornamento pubblicato
2026-02-25
Data di completamento (stimata)
2029-01-01
Arruolamento (previsto)
80
Tipo di studio
Interventistico
FASE
Fase II
Stato
Non ancora in arruolamento
Parole chiave
Pediatric
Transcutaneous Spinal Stimulation
Transcutaneous Spinal Stimulation
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivotSCS + Functional Activity Training Transcutaneous spinal cord stimulation will be paired with training based on Aim.
Participants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS.
Participants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate. | tSCS Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation and activity based training. Stimulation intensity will be based on involuntary motor threshold, determined during a MEPs assessment. Functional Activity Training All participants will engage in functional activity training based on Aim. Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation (tSCS) and activity based training.
Participants in Aim 1 will complete gait training. Participants in Aim 2 will complete activity-based training. |
SperimentaletSCS + Functional Activity Training + 5-Azacitidine Transcutaneous spinal cord stimulation will be paired with training based on Aim.
Participants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS.
Participants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate.
A subset of opt-in participants will also be ra...Mostra di più | tSCS Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation and activity based training. Stimulation intensity will be based on involuntary motor threshold, determined during a MEPs assessment. 5-Azacitidine A subset of opt-in participants will receive a single subcutaneous injection of 5-Azacitidine at a dose of 75 mg/m² Functional Activity Training All participants will engage in functional activity training based on Aim. Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation (tSCS) and activity based training.
Participants in Aim 1 will complete gait training. Participants in Aim 2 will complete activity-based training. |
Comparatore attivotSCS + Functional Activity Training + Mannitol (Placebo) Transcutaneous spinal cord stimulation will be paired with training based on Aim.
Participants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS.
Participants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate.
A subset of opt-in participants will also be ra...Mostra di più | tSCS Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation and activity based training. Stimulation intensity will be based on involuntary motor threshold, determined during a MEPs assessment. Mannitolo A subset of opt-in participants will receive a single subcutaneous injection of Mannitol (placebo) at a dose of 75 mg/m². Functional Activity Training All participants will engage in functional activity training based on Aim. Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation (tSCS) and activity based training.
Participants in Aim 1 will complete gait training. Participants in Aim 2 will complete activity-based training. |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Spatiotemporal Gait Symmetry via Instrumented Gait-Mat | For Aim 1 participants (GMFCS levels 1-3), an instrumented gait-mat will be used to assess spatiotemporal gait symmetry. | Baseline to Follow-Up, approximately 22 weeks |
Modified Tardieu Scale | For Aim 2 participants (GMFCS levels 4-5), muscle spasticity will be assessed using the Modified Tardieu Scale. | Baseline to Follow-Up, approximately 22 weeks |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino
Età minima
4 Years
Sessi idonei
Tutti
- Diagnosis of cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) Levels I-V.
- Between 4 and 17 years old at the time of enrollment/consent.
- Diagnosis of spastic CP hemiplegia, diplegia, or quadriplegia.
- Stable medical condition as determined by the investigator.
- Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator.
- Capable of performing simple cued motor tasks and can follow 2-3 step commands.
- Capable of communicating an accurate yes or no answer to questions according to parent or guardian.
- Able to localize pain/ discomfort.
- Physician approval for participation.
- Parent/ guardian permission.
- Concurrent neurological disease affecting the central nervous system.
- Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
- Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the upper and/or lower extremity
- Unhealed fracture or other musculoskeletal impairment that might interfere with upper or lower extremity rehabilitation or testing activities
- Implanted stimulator (e.g., epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant) or drug delivery device (e.g., baclofen pump)
- Dependence on an electro-magnetic medical implant (e.g., cardiac pacemaker, implanted drug pump), ventilation support, or another external device.
- History of uncontrolled seizures
- Unexplained presence of persistent complaints of pain of any kind
- Unable to localize pain/discomfort
- Severe cortico-visual impairment
- Active pressure sores
- Active urinary tract infection
- Active cancer or cancer in remission less than 5 years
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse
- Immunodeficiency or hematologic condition
- Allergy to AZA or mannitol
- Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 10
- Pregnancy
- Orthopedic surgery completed in the prior 12 months
- Intrathecal medication titration that may affect muscle spasticity
- Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the treating physician
- Current enrollment in a conflicting research study
- Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the investigator or treating physician
Shirley Ryan AbilityLabParte responsabile dello studio
Arun Jayaraman, PT, PhD, Investigatore principale, Scientific Chair, Technology & Innovation, Shirley Ryan AbilityLab
Contatti principali dello studio
Contatto: Audrey Wiesner, BS, 3122388435, [email protected]
Contatto: Jacklyn Stoller, PT, DPT, 3122387620, [email protected]
1 Centri dello studio in 1 paesi
Illinois
Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States
Arun Jayaraman, PhD, Investigatore principale