Mechanism Study of tDCS on Human Electrophysiological Network Via SEEG

NCT04610268 | Unknown

• 1 other identifier: 2018-145
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial direct current stimulation(tDCS) is a non-invasive Neuromodulation method.The weak direct current produced by tDCS can be transmitted through the skull and induce biphase, polarization-related changes in the cortex. Related clinical studies have found that tDCS has a corresponding therapeutic effect on neurological and psychiatric diseases such as stroke rehabilitation, depression, pain, epilepsy, etc. 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.

Conditions

Depression

Keywords

Transcranial direct current stimulation (tDCS); Stereotactic electroencephalography (sEEG); Focal refractory epilepsy

Outcome Measures

Primary Outcomes (3)

• Voltage difference

  Voltage difference between stimulation electrodes.

  intraoperative

• Stimulus current

  Stimulus current between stimulation electrodes.

  intraoperative

• sEEG voltage

  Respectively, 2 to 4 sEEG electrodes with distance of more than 2 cm were selected along the sagittal plane direction and coronal plane direction, and the voltage of each channel on the electrode was recorded.

  intraoperative

Study Arms (1)

tDCS group

EXPERIMENTAL

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.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

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).

tDCS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SEEG is required for preoperative evaluation in patients with focal refractory epilepsy, consent and sign the informed consent for treatment.

You may not qualify if:

• (1) history of major depression or mental disorder and medication history causing symptoms of mental disorder,
• (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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Qiushi Academy for Advanced Studies, Zhejiang University: collaborator

Study Sites (1)

SAHZhejiangU

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Hongjie Jiang, Dr.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Hongjie Jiang, Dr.

CONTACT

+86 13777830137; insjhj@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: October 30, 2020
• Study Start: November 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-09

Locations

CN (1)