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Awake Intraoperative Language Mapping and Chinese Probabilistic Map Construction

NCT03641391 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-08-22

No results posted yet for this study

Summary

The study aims at constructing a Chinese language probabilistic map by awake intraoperative direct electrical stimulation (DES) language mapping. At the same time, the standardization and optimization of awake intraoperative DES parameters will be explored, factors affecting postoperative function morbidity and survival will also be analyzed.

Conditions

Interventions

PROCEDURE

Intraoperative direct cortical electrical stimulation

Intraoperative direct electrical stimulation on language or language-associate cortex, was performed using a 5-mm wide bipolar electrode with a pulse frequency of 60 Hz and an amplitude of 1.5 to 6 milliamperage. The somatosensory evoked potential was recorded with a 6-contact subdural strip electrode. If after-discharge activity indicated that the stimulation current was too high, the current amplitude was decreased by 0.5 to 1 milliamperage. The participants would be undergone awake anesthesia and asked to perform language tasks during the stimulation.

PROCEDURE

Intraoperative direct subcortical electrical stimulation

Intraoperative direct electrical stimulation on language or language-associate subcortical pathways, was performed using a biphasic square-wave pulse delivered at 60 Hz with a current amplitude ranging from 1.5 to 10 milliamperage. The somatosensory evoked potential was recorded with a 6-contact subdural strip electrode. If after-discharge activity indicated that the stimulation current was too high, the current amplitude was decreased by 0.5 to 1 milliamperage. The participants would be undergone awake anesthesia and asked to perform language tasks during the stimulation.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Huashan Hospital North, Fudan University

    collaborator UNKNOWN

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Jinsong Wu, MD · Huashan Hospital

  • Dongxiao Zhuang, MD · Huashan Hospital

  • Tianming Qiu, MD · Huashan Hospital

  • Junfeng Lu, MD · Huashan Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03641391 on ClinicalTrials.gov