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

2 juni 2019 bijgewerkt door: 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

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Verwacht)

106

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Werving
        • Huashan Hospital Affiliated to Fudan University
        • Contact:
        • Hoofdonderzoeker:
          • Jinsong Wu, MD
        • Onderonderzoeker:
          • Dongxiao Zhuang, MD
        • Onderonderzoeker:
          • Tianming Qiu, MD
        • Onderonderzoeker:
          • Jie Zhang, MD
        • Contact:
        • Onderonderzoeker:
          • ruiping Hu, MD
        • Onderonderzoeker:
          • Qiao Shan, MD
        • Onderonderzoeker:
          • Chengxin Ma, MD
      • Shanghai, Shanghai, China, 200040
        • Werving
        • Shanghai Jing'an Central Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Combinatie product: 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).
Andere namen:
  • speech rehabilitation training
Sham-vergelijker: 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.
Combinatie product: 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).
Andere namen:
  • speech rehabilitation training

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Boston naming test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Huashan Hospital

Medewerkers

Shanghai Jing'an Central Hospital
Huashan Hospital North Hospital

Onderzoekers

  • Hoofdonderzoeker: Jinsong Wu, MD, Huashan Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 oktober 2018

Primaire voltooiing (Verwacht)

30 april 2021

Studie voltooiing (Verwacht)

30 oktober 2021

Studieregistratiedata

Eerst ingediend

20 mei 2019

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2019

Eerst geplaatst (Werkelijk)

5 juni 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2019

Laatst geverifieerd

1 oktober 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KY2018-395

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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