Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients
Through the Navigation Transcranial Magnetic Stimulation Over the Language Key Areas of Cerebellar to Enhance Language Function Recovery After Brain Tumor Resection
1 other identifier
interventional
106
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2018
CompletedFirst Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
June 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedJune 5, 2019
October 1, 2018
2.5 years
May 20, 2019
June 2, 2019
Conditions
Outcome Measures
Primary Outcomes (6)
Boston naming test
The change of Boston naming test scores is being assessed
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
MMSE
The change of Mini-mental State Examination scores is being assessed
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
ABC
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
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
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
The change of functional connectivity of cerebellar network is being assessed
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Study Arms (2)
Theta Burst Stimulation
ACTIVE COMPARATORIntervention 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.
sham Theta Burst Stimulation
SHAM COMPARATORsham 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
- Shanghai Jing'an Central Hospitalcollaborator
- Huashan Hospital North Hospitalcollaborator
Study Sites (2)
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Jing'an Central Hospital
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinsong Wu, MD
Huashan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
May 20, 2019
First Posted
June 5, 2019
Study Start
October 30, 2018
Primary Completion
April 30, 2021
Study Completion
October 30, 2021
Last Updated
June 5, 2019
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share