Mechanism Study of tDCS on Human Electrophysiological Network Via SEEG
NCT ID: NCT04610268
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4 participants
INTERVENTIONAL
2020-11-01
2020-12-31
Brief Summary
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Stereotactic electroencephalography(sEEG) implants a set of deep electrodes into the brain that use stereotactic localization to detect electrical activity, locate epileptic foci and functional areas, and detect changes in electrical fields caused by tDCS in the deep brain. This direct measurement technology will provide validation and optimization for the electric field simulation method based on finite element analysis (FEM), also complement the latest indirect current density intensity measurement technology based on MRI phase measurement, providing support for the targeting and personalized treatment of tDCS technology.
In order to achieve this goal and study the mechanism and function of tDCS better , this project aims to realize the clinical use of sEEG to measure the electric field information generated by tDCS in the human brain in vivo.
Detailed Description
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1. Transcranial electrical stimulation and intracranial space electric field measurement system based on sEEG and tDCS.
Multi-channel transcranial direct current stimulation technology is studied to realize the integration of parameters setting, constant current output, overcurrent protection, electrode connection status detection and other modules. Based on sEEG intracranial electric field measurement system, weak electric field measurement with spatial positioning information can be realized accurately. The integrated control system of transcranial electric stimulation and intracranial space electric field recording was studied to realize the linkage control of multi-channel tDCS and space electric field recording and data processing and analysis.
2. Clinical implementation protocol design of tDCS combined with sEEG.
To study the implementation protocol of tDCS combined sEEG applicable to clinical practice, and to develop inclusion and exclusion criteria for clinical volunteers, based on MRI data and actual disease conditions of volunteers, individual differentiation planning of sEEG implantation and stimulation parameters and stimulation sites of combined tDCS; Intraoperative sEEG-based intracranial spatial electric field measurement protocols were studied, including implementation procedures for tDCS stimulation and sEEG recording, individualized experimental paradigm design, practical procedures and data recording.
3. Individual head model electric field simulation analysis method.
An electric field distribution simulation model based on individual head model was established to realize the finite element simulation calculation of spatial electric field distribution under different individual head model structure, different electrical properties of tissues, different tDCS stimulation combinations and stimulation parameters. According to the electric field data recorded by sEEG and MRI data, the actual electric field distribution model of individual head model was established. The spatial electric field distribution characteristics of tDCS acting on different intracranial depths and distances were analyzed under different external stimulation parameters, and compared with the simulation model. The existing simulation model is optimized based on the measured data.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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tDCS group
The anode of tDCS is placed on the occipital lobe and the cathode on the frontal lobe, or the anode of tDCS is placed on the left temporal lobe and the cathode on the right temporal lobe.
transcranial direct current stimulation
Depending on the location of sEEG electrode implanted in the patient's head, the tDCS electrode (5 cm×7 cm each) was placed on occipital-frontal lobe or bilateral temporal lobe. Current intensity: 2 mA and 4 mA, Stimulus time: 3 min (each stimulus session).
Interventions
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transcranial direct current stimulation
Depending on the location of sEEG electrode implanted in the patient's head, the tDCS electrode (5 cm×7 cm each) was placed on occipital-frontal lobe or bilateral temporal lobe. Current intensity: 2 mA and 4 mA, Stimulus time: 3 min (each stimulus session).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* (2) patients with severe cognitive impairment (MMSE score\<17),
* (3) craniocerebral surgery history,
* (4) severe head skin disease (including but not limited to purpura, blisters, rash, eczema) or open head injury/laceration,
* (5) existing known risk factors of tDCS: A. use of implanted electronic devices (such as pacemakers) or metal implants (such as stents), B. a history of injury to unfixed metal in any part of the body (including metal objects in the eye), C. pregnant woman;D. cancer patients, patients in critical condition or patients with important organ failure, E. severe allergy to the electrode patch, local skin injury or inflammation, and hyperalgesia in the stimulation area, F. scalp injury that may cause poor application of tDCS.
18 Years
70 Years
ALL
No
Sponsors
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Qiushi Academy for Advanced Studies, Zhejiang University
UNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Hongjie Jiang, Dr.
Role: STUDY_CHAIR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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SAHZhejiangU
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Hongjie Jiang, Dr.
Role: primary
Other Identifiers
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2018-145
Identifier Type: -
Identifier Source: org_study_id