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

2. juni 2019 oppdatert av: 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

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

106

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina, 200040
        • Rekruttering
        • Huashan Hospital Affiliated to Fudan University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jinsong Wu, MD
        • Underetterforsker:
          • Dongxiao Zhuang, MD
        • Underetterforsker:
          • Tianming Qiu, MD
        • Underetterforsker:
          • Jie Zhang, MD
        • Ta kontakt med:
        • Underetterforsker:
          • ruiping Hu, MD
        • Underetterforsker:
          • Qiao Shan, MD
        • Underetterforsker:
          • Chengxin Ma, MD
      • Shanghai, Shanghai, Kina, 200040
        • Rekruttering
        • Shanghai Jing'an Central Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Kombinasjonsprodukt: 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).
Andre navn:
  • speech rehabilitation training
Sham-komparator: 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.
Kombinasjonsprodukt: 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).
Andre navn:
  • speech rehabilitation training

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Boston naming test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Huashan Hospital

Samarbeidspartnere

Shanghai Jing'an Central Hospital
Huashan Hospital North Hospital

Etterforskere

  • Hovedetterforsker: Jinsong Wu, MD, Huashan Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. oktober 2018

Primær fullføring (Forventet)

30. april 2021

Studiet fullført (Forventet)

30. oktober 2021

Datoer for studieregistrering

Først innsendt

20. mai 2019

Først innsendt som oppfylte QC-kriteriene

2. juni 2019

Først lagt ut (Faktiske)

5. juni 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. juni 2019

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KY2018-395

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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