Cerebellar FunctionNCT03974659
Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients
A study testing Transcranial magnetic stimulation in people with Cerebellar Function and Transcranial Magnetic Stimulation, run by Huashan Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebellar Function, Transcranial Magnetic Stimulation, Language Disorders
- What is being tested?
- Transcranial magnetic stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 2 sitesChina
- Study dates
- 30 Oct 2018to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Jinsong Wu, MD, 86-021-52887200, wjsongc@126.com
Tianming Qiu, MD, 86-021-52887200, Tianming2100@126.com
- Recruiting
Shanghai Jing'an Central Hospital
Shanghai, Shanghai Municipality, 200040
Qingyang Luo, MD, 021-61578000, luoqingyang529@sina.com
About this study
Official title: 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
Read the 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.
- Being tested
- Transcranial magnetic stimulation
- Medical subject headings
- Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationCombination product
Also called speech rehabilitation training
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).
| Study group | Role | What they receive |
|---|---|---|
| Theta Burst Stimulation | Active comparator | 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. Receives: Combination Product: Transcranial magnetic stimulation |
| sham Theta Burst Stimulation | Sham comparator | 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. Receives: Combination Product: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston naming test
The change of Boston naming test scores is being assessed
Measured: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
MMSE
The change of Mini-mental State Examination scores is being assessed
Measured: 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
Measured: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
ALFF
The change of Cerebellar spontaneous neurological activity level is being assessed
Measured: 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
Measured: 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
Measured: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start30 Oct 2018
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar FunctionStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective Randomized, Double-Blind Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jing'an Central Hospital
- Responsible party
- Principal investigator, Jinsong Wu, Huashan Hospital
- Investigators
- Jinsong Wu, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974659
- Sponsor's protocol ID
- KY2018-395
- Status last verified
- Oct 2018
- First submitted
- 20 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Through the Navigation Transcranial Magnetic Stimulation Over the Language Key Areas of Cerebellar to Enhance Language Function Recovery After Brain Tumor Resection
- ClinicalTrials.gov ID
- NCT03974659
- Acronym / sponsor ID
- KY2018-395
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jing'an Central Hospital
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Prospective Randomized, Double-Blind Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Theta Burst Stimulation | Active comparator | Combination Product: Transcranial magnetic stimulationIntervention 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 comparator | Combination Product: Transcranial magnetic stimulationsham 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationAlso: speech rehabilitation training1.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). | Combination product | Theta Burst Stimulation, sham Theta Burst Stimulation |
Primary outcome
Boston naming test
Time frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Boston naming test scores is being assessed
MMSE
Time frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Mini-mental State Examination scores is being assessed
ABC
Time frame: 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
ALFF
Time frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Cerebellar spontaneous neurological activity level is being assessed
Cerebellar gray matter volume
Time frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Cerebellar gray matter volume is being assessed
Functional connectivity of cerebellar network
Time frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of functional connectivity of cerebellar network is being assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Cerebellar Function
Active, not recruiting
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Friedreich Ataxia
Recruiting
Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome.
Friedreich's Ataxia, Motor Disorders
Recruiting
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Schizophrenia, Cerebellar Function
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Home Exercise for Individuals With Neurodegenerative Disease
Neurodegenerative Diseases, Leukodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinsong Wu, MD principal investigator
Huashan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Cerebellar Function and Transcranial Magnetic Stimulation, run by Huashan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsong Wu, MD (86-021-52887200, wjsongc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston naming test (time frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.