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Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients

2 giugno 2019 aggiornato da: Jinsong Wu, Huashan Hospital

Through the Navigation Transcranial Magnetic Stimulation Over the Language Key Areas of Cerebellar to Enhance Language Function Recovery After Brain Tumor Resection

At present, the incidence of language dysfunction in patients with brain language area tumor in the first month after operation was 20%-40%. The investigator's team has confirmed and found that bilateral cerebellar VIIa lobules are the critical areas of cerebellar which is closely related to the language function of the patients. This study aims at enhancing language function recovery after surgery through the transcranial magnetic stimulation stimulates the key areas of cerebellar.

This study is a prospective, randomized, double-blind, multi-center clinical trial in which participants with postoperative aphasia in the brain-language region tumors of three neurosurgery departments, Huashan Hospital, Shanghai Jing'an Center Hospital and Huashan Hospital North Hospital. Participants were randomly divided into Intervention group and control group. Before transcranial magnetic stimulation treatment, the two groups were required to conduct language behavior assessment and magnetic resonance imaging data. Participants in both groups were given 10 consecutive days bilateral cerebellar VIIa lobules Theta Burst Stimulation from one week after surgery and received speech rehabilitation training after stimulation.

The investigators collect patients MRI data and language behavioral assessment scores at 1week post operation and 1 month after the operation and 3 months after the operation. Subsequently, three MRI data and language behavioral assessment scores were processed and statistically analyzed to compare the differences between the two groups

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Intervention group: Intermittent Theta Burst Stimulation(Positive stimulation) is used in right cerebellar VIIa lobule. Continuous Theta Burst Stimulation(Negative stimulation) is used in left cerebellar VIIa lobule. The stimulation intensity was 80% Rest Motor Threshold.According to the patients' condition, age and tolerance,the intensity should be adjusted.

Control group: The investigators use with fake stimulation , the appearance is the same as the magnetic stimulator used in the experimental group, and the stimulation will also make sounds, but no magnetic field effect, the stimulation mode is the same as the intervention group.

Subsequently, The investigators collect patients MRI data and language behavioral assessment scores at 1week post operation and 1 month after the operation and 3 months after the operation.three times MRI data and language behavioral assessment scores were processed and statistically analyzed to compare the differences between the two groups from the cerebellar spontaneous neurological activity level (ALFF), cerebellar gray matter volume, functional connectivity of cerebellar network and language behavioral score.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

106

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Shanghai
      • Shanghai, Shanghai, Cina, 200040
        • Reclutamento
        • Huashan Hospital Affiliated to Fudan University
        • Contatto:
          • Jinsong Wu, MD
          • Numero di telefono: 86-021-52887200
          • Email: wjsongc@126.com
        • Investigatore principale:
          • Jinsong Wu, MD
        • Sub-investigatore:
          • Dongxiao Zhuang, MD
        • Sub-investigatore:
          • Tianming Qiu, MD
        • Sub-investigatore:
          • Jie Zhang, MD
        • Contatto:
        • Sub-investigatore:
          • ruiping Hu, MD
        • Sub-investigatore:
          • Qiao Shan, MD
        • Sub-investigatore:
          • Chengxin Ma, MD
      • Shanghai, Shanghai, Cina, 200040
        • Reclutamento
        • Shanghai Jing'an Central Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Language dysfunction after brain tumor surgery (aphasia quotient,AQ)< 93.8
  • Chinese mother tongue
  • Right handedness confirmed by Edinburgh Handedness Scale
  • Tumor patients with linguistic region involvement in the dominant hemisphere
  • Karnofsky Performance Status (KPS)< 70
  • Voluntary participation in this project

Exclusion Criteria:

  • Patients with frequent epileptic seizures (> 2 epilepsy episodes per week)
  • Previous implants of metal pacemakers, stimulators, hearing aids, dentures, and insulin pumps or claustrophobia
  • People with a history of psychiatric disorders
  • Patients with severe medical diseases
  • Patients with Alzheimer's disease and Parkinson's disease. Medical diseases
  • Pregnant women
  • Other clinical trials in the same period.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Theta Burst Stimulation

Intervention group: ten consecutive days bilateral cerebellar VIIa lobules Theta Burst Stimulation.

Intermittent Theta Burst Stimulation(Positive stimulation) is used in right cerebellar VIIa lobule.Each stimulus had three 50 Hz monopulses, which were repeated every 200 ms. Each stimulation continued for 2 seconds and rested for 8 seconds. The total intervention time was 200s (600 pulses) Continuous Theta Burst Stimulation(Negative stimulation) is used in left cerebellar VIIa lobule,three 50 Hz monopulses in each stimulus, each with an interval of 200 ms, and each intervention lasted 40s (600 pulses).

The stimulation intensity was 80% Rest Motor Threshold.According to the patients' condition, age and tolerance,the intensity should be adjusted.
Prodotto combinato: Transcranial magnetic stimulation
1.Patients were given 10 consecutive days bilateral cerebellar VIIa lobules Theta Burst Stimulation which was a special mode of Transcranial magnetic stimulation from one week after surgery Intermittent Theta Burst Stimulation(Positive stimulation) is used in right cerebellar VIIa lobule.Each stimulus had three 50 Hz monopulses, which were repeated every 200 ms. Each stimulation continued for 2 seconds and rested for 8 seconds. The total intervention time was 200s (600 pulses) Continuous Theta Burst Stimulation(Negative stimulation) is used in left cerebellar VIIa lobule,three 50 Hz monopulses in each stimulus, each with an interval of 200 ms, and each intervention lasted 40s (600 pulses).
Altri nomi:
  • speech rehabilitation training
Comparatore fittizio: sham Theta Burst Stimulation
sham group: we flip coil to make fake stimulation, the stimulation will also make sounds, but no magnetic field effect, the stimulation mode is the same as the intervention group.
Prodotto combinato: Transcranial magnetic stimulation
1.Patients were given 10 consecutive days bilateral cerebellar VIIa lobules Theta Burst Stimulation which was a special mode of Transcranial magnetic stimulation from one week after surgery Intermittent Theta Burst Stimulation(Positive stimulation) is used in right cerebellar VIIa lobule.Each stimulus had three 50 Hz monopulses, which were repeated every 200 ms. Each stimulation continued for 2 seconds and rested for 8 seconds. The total intervention time was 200s (600 pulses) Continuous Theta Burst Stimulation(Negative stimulation) is used in left cerebellar VIIa lobule,three 50 Hz monopulses in each stimulus, each with an interval of 200 ms, and each intervention lasted 40s (600 pulses).
Altri nomi:
  • speech rehabilitation training

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Boston naming test
Lasso di tempo: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Boston naming test scores is being assessed
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
MMSE
Lasso di tempo: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Mini-mental State Examination scores is being assessed
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
ABC
Lasso di tempo: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Aphasia Battery of Chinese，Conclude naming, repeating, comprehend and spontaneous speech test，The change of ABC scores is being assessed
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
ALFF
Lasso di tempo: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Cerebellar spontaneous neurological activity level is being assessed
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Cerebellar gray matter volume
Lasso di tempo: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Cerebellar gray matter volume is being assessed
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Functional connectivity of cerebellar network
Lasso di tempo: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of functional connectivity of cerebellar network is being assessed
Change from postoperative 1 week to postoperative 1month & postoperative 3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Huashan Hospital

Collaboratori

Shanghai Jing'an Central Hospital
Huashan Hospital North Hospital

Investigatori

  • Investigatore principale: Jinsong Wu, MD, Huashan Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 ottobre 2018

Completamento primario (Anticipato)

30 aprile 2021

Completamento dello studio (Anticipato)

30 ottobre 2021

Date di iscrizione allo studio

Primo inviato

20 maggio 2019

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2019

Primo Inserito (Effettivo)

5 giugno 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2019

Ultimo verificato

1 ottobre 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KY2018-395

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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