Clinical trial NCT03974659: Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients
Official title: Through the Navigation Transcranial Magnetic Stimulation Over the Language Key Areas of Cerebellar to Enhance Language Function Recovery After Brain Tumor Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebellar Function
Transcranial Magnetic Stimulation
Language Disorders
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jing'an Central Hospital
name: Huashan Hospital North Hospital
First posted: 2019-06-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective Randomized, Double-Blind Clinical Trial
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Boston naming test
timeFrame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
measure: MMSE
timeFrame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
measure: ABC
timeFrame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
measure: ALFF
timeFrame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
measure: Cerebellar gray matter volume
timeFrame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
measure: Functional connectivity of cerebellar network
timeFrame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jing'an Central Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jinsong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: