NCT04706338

Brief 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 supplementary motor area on the lesional hemisphere.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

January 10, 2021

Last Update Submit

January 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the day of tumor resection to 3 months after tumor resection.

Study Arms (1)

TMS treatment

EXPERIMENTAL

Patients with TMS treatment

Device: TMS treatment

Interventions

Using TMS to stimulate (5 Hz, 90%\~110% resting motor threshold) patients' primary motor area and SMA.

TMS treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • patients with contraindication of transcranial magnetic stimulation;
  • patients without data of the pre- and postoperative resting state MRI and diffusion tensor image.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 29111342BACKGROUND
  • Lefaucheur 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.

    PMID: 31901449BACKGROUND

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Jiang Tao

    Beijing Neurosurgical Institute

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: patients with postoperative motor deficits, especially for patients with SMA syndrome.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2021

First Posted

January 12, 2021

Study Start

January 15, 2021

Primary Completion

June 1, 2021

Study Completion

January 1, 2022

Last Updated

January 14, 2021

Record last verified: 2021-01

Locations