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Transcranial Magnetic Stimulation in the Rehabilitation of Postoperative Motor Dysfunction. (ATM)

Primary Purpose

Glioma, Postoperative Motor Deficit

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TMS treatment
Sponsored by
Beijing Neurosurgical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patient underwent awake craniotomy and motor functional identification during tumor resection;
  2. patients with postoperative motor deficit (muscle strength of limbs is weaker than preoperative status)

Exclusion Criteria:

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

Sites / Locations

  • Beijing Neurosurgical Institute and Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TMS treatment

Arm Description

Patients with TMS treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2021
Last Updated
January 12, 2021
Sponsor
Beijing Neurosurgical Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04706338
Brief Title
Transcranial Magnetic Stimulation in the Rehabilitation of Postoperative Motor Dysfunction.
Acronym
ATM
Official Title
A Study of Transcranial Magnetic Stimulation in the Rehabilitation of Glioma Patients With Postoperative Motor Dysfunction.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Neurosurgical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Postoperative Motor Deficit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients with postoperative motor deficits, especially for patients with SMA syndrome.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMS treatment
Arm Type
Experimental
Arm Description
Patients with TMS treatment
Intervention Type
Device
Intervention Name(s)
TMS treatment
Intervention Description
Using TMS to stimulate (5 Hz, 90%~110% resting motor threshold) patients' primary motor area and SMA.
Primary Outcome Measure Information:
Title
Accelerate motor functional recovery
Description
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.
Time Frame
From the day of tumor resection to 3 months after tumor resection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: patients with contraindication of transcranial magnetic stimulation; patients without data of the pre- and postoperative resting state MRI and diffusion tensor image.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengyu Fang, MD
Phone
+8613466331405
Email
fangtuo1@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yinyan Wang, MD
Phone
+8613581688953
Email
tiantanyinyan@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Tao
Organizational Affiliation
Beijing Neurosurgical Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Jiang, MD and PhD
Phone
+86-010-67021832
Email
taojiang1964@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The treatment protocal of TMS for glioma patients with postoperative motor dysfunction
Citations:
PubMed Identifier
29111342
Citation
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.
Results Reference
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PubMed Identifier
31901449
Citation
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. Erratum In: Clin Neurophysiol. 2020 May;131(5):1168-1169.
Results Reference
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Transcranial Magnetic Stimulation in the Rehabilitation of Postoperative Motor Dysfunction.

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