GliomaATMNCT04706338
Transcranial Magnetic Stimulation in the Rehabilitation of Postoperative Motor Dysfunction.
A study testing TMS treatment in people with Glioma and Postoperative Motor Deficit, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
This study focused on glioma patients with postoperative motor deficits, especially for patients with supplementary motor area syndrome. The investigators want to investigate whether the recovery of motor function will be accelerated by using transcranial magnetic stimulation to stimulate primary motor area and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma, Postoperative Motor Deficit
- What is being tested?
- TMS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2021to 1 Jan 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient underwent awake craniotomy and motor functional identification during tumor resection;
- patients with postoperative motor deficit (muscle strength of limbs is weaker than preoperative status)
Who cannot join
- patients with contraindication of transcranial magnetic stimulation;
- patients without data of the pre- and postoperative resting state MRI and diffusion tensor image.
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: A Study of Transcranial Magnetic Stimulation in the Rehabilitation of Glioma Patients With Postoperative Motor Dysfunction.
This study focused on glioma patients with postoperative motor deficits, especially for patients with supplementary motor area syndrome. The investigators want to investigate whether the recovery of motor function will be accelerated by using transcranial magnetic stimulation to stimulate primary motor area and supplementary motor area on the lesional hemisphere.
- Conditions
- Glioma, Postoperative Motor Deficit
- Being tested
- TMS treatment
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS treatmentDevice
Using TMS to stimulate (5 Hz, 90%~110% resting motor threshold) patients' primary motor area and SMA.
| Study group | Role | What they receive |
|---|---|---|
| TMS treatment | Experimental | Patients with TMS treatment Receives: Device: TMS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerate motor functional recovery
The ratio of motor functional recovery in patients with TMS treatment is higher than those do not receive TMS treatment and the time of motor funcitonal recovery is shorter than those do not receive.
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 posted12 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jan 2022 (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 GliomaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- patients with postoperative motor deficits, especially for patients with SMA syndrome.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiang Tao, Study chair, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706338
- Sponsor's protocol ID
- KY-2020-128-01
- Acronym
- ATM
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The treatment protocal of TMS for glioma patients with postoperative motor dysfunction
Publications
Dionisio A, Duarte IC, Patricio M, Castelo-Branco M. The Use of Repetitive Transcranial Magnetic Stimulation for Stroke Rehabilitation: A Systematic Review. J Stroke Cerebrovasc Dis. 2018 Jan;27(1):1-31. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.008. Epub 2017 Oct 27.
PubMed 29111342Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Transcranial Magnetic Stimulation in the Rehabilitation of Glioma Patients With Postoperative Motor Dysfunction.
- ClinicalTrials.gov ID
- NCT04706338
- Acronym / sponsor ID
- ATM / KY-2020-128-01
- Conditions
- Glioma, Postoperative Motor Deficit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 12 Jan 2021 (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.
This study focused on glioma patients with postoperative motor deficits, especially for patients with supplementary motor area syndrome. The investigators want to investigate whether the recovery of motor function will be accelerated by using transcranial magnetic stimulation to stimulate primary motor area and supplementary motor area on the lesional hemisphere.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with postoperative motor deficits, especially for patients with SMA syndrome.
| Arm | Type | Receives |
|---|---|---|
| TMS treatment | Experimental | Device: TMS treatmentPatients with TMS treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient underwent awake craniotomy and motor functional identification during tumor resection;
- patients with postoperative motor deficit (muscle strength of limbs is weaker than preoperative status)
Key exclusion criteria (2 listed)
- patients with contraindication of transcranial magnetic stimulation;
- patients without data of the pre- and postoperative resting state MRI and diffusion tensor image.
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 treatmentUsing TMS to stimulate (5 Hz, 90%~110% resting motor threshold) patients' primary motor area and SMA. | Device | TMS treatment |
Primary outcome
Accelerate motor functional recovery
Time frame: From the day of tumor resection to 3 months after tumor resection.
The ratio of motor functional recovery in patients with TMS treatment is higher than those do not receive TMS treatment and the time of motor funcitonal recovery is shorter than those do not receive.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 29111342Dionisio A, Duarte IC, Patricio M, Castelo-Branco M. The Use of Repetitive Transcranial Magnetic Stimulation for Stroke Rehabilitation: A Systematic Review. J Stroke Cerebrovasc Dis. 2018 Jan;27(1):1-31. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.008. Epub 2017 Oct 27.
- Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Individual participant dataSharing planned: Undecided. The treatment protocal of TMS for glioma patients with postoperative motor dysfunction
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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.
Jiang Tao study chair
Beijing Neurosurgical Institute
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 treatment in people with Glioma and Postoperative Motor Deficit, 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 2 inclusion and 2 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 14 Jan 2021. 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. 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?
Accelerate motor functional recovery (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 NCT04706338, 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 14 Jan 2021.