Motor Cortex; LesionNCT05803057
Accelerating Motor Recovering in Patients With SMA Syndrome After Glioma Surgery by Using nrTMS
A study testing TMS stimulation treatment in people with Motor Cortex; Lesion and Glioma, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
The goal of this randomized clinical controlled trial is to learn about whether neuro-navigation repetitive transcranial magnetic stimulation (nrTMS) was useful to accelerate the recovery in patients with SMA syndrome after glioma resection. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Motor Cortex; Lesion, Glioma, Supplementary Motor Area Syndrome
- What is being tested?
- TMS stimulation treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Mar 2025
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital
- Right-handed, age: 25-55 years old
- Tumor located in supplementary motor area
- No previous treatment history of central nervous system disease
- The patient received awaken craniotomy
- Pathological diagnosis is low grade glioma
- Volunteer to accept nrTMS treatment
Who cannot join
- The tumor grows across the midline to the opposite side
- Regarding rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °
- The patient did not have SMA syndrome after operation
- Vulnerable or special groups and protective measures, such as pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100005
Tao Jiang, MD and PhD, +86-010-67021832, taojiang1964@163.com
About this study
Official title: Beijing Neurosurgical Institute, Beijing, China
The goal of this randomized clinical controlled trial is to learn about whether neuro-navigation repetitive transcranial magnetic stimulation (nrTMS) was useful to accelerate the recovery in patients with SMA syndrome after glioma resection. The main questions aim to answer:
- Question 1: Whether the nrTMS was useful to accelerate the recovery of motor function back to the preoperative status in participants with SMA syndrome after glioma resection.
- Question 2: Whether the nrTMS was useful to improve postoperative motor function in participants with SMA syndrome after glioma resection.
Participants will continue to receive nrTMS treatment or nrTMS sham-treatment for 7 times on the 8th day after glioma resection to determine whether the TMS was helpful for exercise rehabilitation. The investigator will evaluate the effects of nrTMS treatment through the ratio of recovery of motor function and the time that was from the participants suffering SMA syndrome to totally recover the motor function to the status of motor function in pre-operation.
Read the detailed description
This study will use the 8-coil (Magstem, England, No.4150) and sham 8-coil (Magstem, England) The criteria of enrolled patients are： A. Inclusion time: from April 01 2023 to March 31 2025 (including the current month); B. Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital; C. Right-handed, age: 25-55 years old, tumor located in SMA, no previous treatment history of nervous system disease; D. The patient received wake-up surgery and applied direct cortical electrical stimulation during the operation to determine the location of the motor area; E. Postoperative pathology was low grade glioma; F. Can accept nrTMS rehabilitation treatment.
The excluding criteria are:
- The tumor grows across the midline to the opposite side; B. When collecting rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °; C. The patient did not have SMA syndrome after operation; D. Vulnerable or special groups and protective measures, such as pregnant women.
- Being tested
- TMS stimulation treatment, TMS stimulation sham-treatment
- Keywords
- human, motor recovery, transcranial magnetic stimulation
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS stimulation treatmentDevice
Using the TMS treatment coli to stimulation with high frequency
TMS stimulation sham-treatmentDevice
Using the TMS sham-treatment coli to stimulation with high frequency
| Study group | Role | What they receive |
|---|---|---|
| TMS treatment | Experimental | Using nrTMS coli to stimulate the thumb related motor cortex with high-frequency. Receives: Device: TMS stimulation treatment |
| TMS Sham-treatment | Sham comparator | Using nrTMS sham-coli to stimulate the thumb related motor cortex with high-frequency. Receives: Device: TMS stimulation sham-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test
The motor function recovers back to the status in pre-operation. The motor status means that the muscle strength muscle of upper limb that is controlled by lesional hemisphere. Moreover, the recovering back means that the muscle strength achieves at grade 5 (healthy grade).
Measured: From the day of tumor resection to 3 months after tumor resection
Secondary outcomes (1)
Motor function improve in evaluating with MRC (the UK Medical Research Council) muscle strength test
The motor function improves compared with the day of SMA syndrome occuring. The motor status means that the strength muscle of upper limb that is controlled by lesional hemisphere. Moreover, the motor imporvement means that the muscle strength is higher than the SMA syndrome occurring but does not achieve grade 5 (healthy grade).
Measured: From the day of tumor resection to 3 months after tumor resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Motor Cortex; LesionStudies of the same condition, open and under way.
- 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
- There are two groups of this study. The one is that the patients receive nrTMS stimulation with high-frequency on the thumb-related motor cortex on the lesional hemisphere. The other is that the patients receive nrTMS sham-stimulation with high-frequency on the thumb-related motor cortex on the lesional hemisphere.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TAO JIANG, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803057
- Sponsor's protocol ID
- 8220101798
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nakajima R, Kinoshita M, Yahata T, Nakada M. Recovery time from supplementary motor area syndrome: relationship to postoperative day 7 paralysis and damage of the cingulum. J Neurosurg. 2019 Feb 8;132(3):865-874. doi: 10.3171/2018.10.JNS182391. Print 2020 Mar 1.
PubMed 30738403Fang S, Li L, Weng S, Zhang Z, Fan X, Jiang T, Wang Y. Increasing nodal vulnerability and nodal efficiency implied recovery time prolonging in patients with supplementary motor area syndrome. Hum Brain Mapp. 2022 Sep;43(13):3958-3969. doi: 10.1002/hbm.25896. Epub 2022 May 4.
PubMed 35507429
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Neurosurgical Institute, Beijing, China
- ClinicalTrials.gov ID
- NCT05803057
- Acronym / sponsor ID
- 8220101798
- Keywords
- human, motor recovery, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 7 Apr 2023 (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.
The goal of this randomized clinical controlled trial is to learn about whether neuro-navigation repetitive transcranial magnetic stimulation (nrTMS) was useful to accelerate the recovery in patients with SMA syndrome after glioma resection. The main questions aim to answer:
- Question 1: Whether the nrTMS was useful to accelerate the recovery of motor function back to the preoperative status in participants with SMA syndrome after glioma resection.
- Question 2: Whether the nrTMS was useful to improve postoperative motor function in participants with SMA syndrome after glioma resection.
Participants will continue to receive nrTMS treatment or nrTMS sham-treatment for 7 times on the 8th day after glioma resection to determine whether the TMS was helpful for exercise rehabilitation. The investigator will evaluate the effects of nrTMS treatment through the ratio of recovery of motor function and the time that was from the participants suffering SMA syndrome to totally recover the motor function to the status of motor function in pre-operation.
Detailed description
This study will use the 8-coil (Magstem, England, No.4150) and sham 8-coil (Magstem, England) The criteria of enrolled patients are： A. Inclusion time: from April 01 2023 to March 31 2025 (including the current month); B. Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital; C. Right-handed, age: 25-55 years old, tumor located in SMA, no previous treatment history of nervous system disease; D. The patient received wake-up surgery and applied direct cortical electrical stimulation during the operation to determine the location of the motor area; E. Postoperative pathology was low grade glioma; F. Can accept nrTMS rehabilitation treatment.
The excluding criteria are:
- The tumor grows across the midline to the opposite side; B. When collecting rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °; C. The patient did not have SMA syndrome after operation; D. Vulnerable or special groups and protective measures, such as pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups of this study. The one is that the patients receive nrTMS stimulation with high-frequency on the thumb-related motor cortex on the lesional hemisphere. The other is that the patients receive nrTMS sham-stimulation with high-frequency on the thumb-related motor cortex on the lesional hemisphere.
| Arm | Type | Receives |
|---|---|---|
| TMS treatment | Experimental | Device: TMS stimulation treatmentUsing nrTMS coli to stimulate the thumb related motor cortex with high-frequency. |
| TMS Sham-treatment | Sham comparator | Device: TMS stimulation sham-treatmentUsing nrTMS sham-coli to stimulate the thumb related motor cortex with high-frequency. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital
- Right-handed, age: 25-55 years old
- Tumor located in supplementary motor area
- No previous treatment history of central nervous system disease
- The patient received awaken craniotomy
Key exclusion criteria (4 listed)
- The tumor grows across the midline to the opposite side
- Regarding rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °
- The patient did not have SMA syndrome after operation
- Vulnerable or special groups and protective measures, such as pregnant women
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 |
|---|---|---|
| TMS stimulation treatmentUsing the TMS treatment coli to stimulation with high frequency | Device | TMS treatment |
| TMS stimulation sham-treatmentUsing the TMS sham-treatment coli to stimulation with high frequency | Device | TMS Sham-treatment |
Primary outcome
Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test
Time frame: From the day of tumor resection to 3 months after tumor resection
The motor function recovers back to the status in pre-operation. The motor status means that the muscle strength muscle of upper limb that is controlled by lesional hemisphere. Moreover, the recovering back means that the muscle strength achieves at grade 5 (healthy grade).
1 secondary outcome
Motor function improve in evaluating with MRC (the UK Medical Research Council) muscle strength test
Time frame: From the day of tumor resection to 3 months after tumor resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 30738403Nakajima R, Kinoshita M, Yahata T, Nakada M. Recovery time from supplementary motor area syndrome: relationship to postoperative day 7 paralysis and damage of the cingulum. J Neurosurg. 2019 Feb 8;132(3):865-874. doi: 10.3171/2018.10.JNS182391. Print 2020 Mar 1.
- Results publication: PubMed 35507429Fang S, Li L, Weng S, Zhang Z, Fan X, Jiang T, Wang Y. Increasing nodal vulnerability and nodal efficiency implied recovery time prolonging in patients with supplementary motor area syndrome. Hum Brain Mapp. 2022 Sep;43(13):3958-3969. doi: 10.1002/hbm.25896. Epub 2022 May 4.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS stimulation treatment in people with Motor Cortex; Lesion and Glioma, run by Beijing Neurosurgical Institute at 1 site 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 7 inclusion and 4 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Shengyu Fang, MD (+8613466331405, fangtuo1@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test (time frame: From the day of tumor resection to 3 months after tumor resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803057, which also lists 2 linked publications.
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 3 May 2023.