Transcranial Magnetic Stimulation in the Rehabilitation of Postoperative Motor Dysfunction.

Glioma Clinical Trial

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Official title:

A Study of Transcranial Magnetic Stimulation in the Rehabilitation of Glioma Patients With Postoperative Motor Dysfunction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706338
• Other study ID #: KY-2020-128-01
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2021
• Source: Beijing Neurosurgical Institute
• Contact: Shengyu Fang, MD
• Phone: +8613466331405
• Email: fangtuo1[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 supplementary motor area on the lesional hemisphere.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• Postoperative Motor Deficit

Intervention

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

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute and Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute

Country where clinical trial is conducted

China, 

References & Publications (2)

Dionísio A, Duarte IC, Patrício 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. Review. — View Citation

Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jääskeläinen 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, Rektorová 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. Review. Erratum in: Clin Neurophysiol. 2020 May;131(5):1168-1169. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.