NCT06076044

Brief Summary

To investigate the effect of transcranial oscillatory direct current stimulation on functions of cerebral cortex (cortical excitability and frequency of eeg) in healthy subjects

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

September 21, 2023

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • MEP

    Motor evoked potentials of the right abductor pollicis brevis were collected

    before treatment and 20, 30, 40, 50, 60 minutes after treatment

  • Power Spectral Density of EEG

    The rest state EEG of the subjects was collected

    before treatment and right after treatment

Study Arms (1)

healthy subjects

EXPERIMENTAL

healthy male subjects aged 20-30 years

Device: toDCS 2mA 1HzDevice: toDCS 2mA 10HzDevice: tDCS 1mADevice: sham

Interventions

The subgroup treated by transcranial oscillatory direct current stimulation of 2mA and 1Hz.

healthy subjects

The subgroup treated by transcranial oscillatory direct current stimulation of 2mA and 10Hz.

healthy subjects
tDCS 1mADEVICE

The subgroup treated by transcranial direct current stimulation of 1mA.

healthy subjects
shamDEVICE

The subgroup treated by sham stimulation.

healthy subjects

Eligibility Criteria

Age20 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe participant eligibility is not based on self-representation of gender identity. The investigators apply the gender eligibility to avoid the influence of female's menstrual cycle.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male
  • Age ranges from 20 to 30 years old
  • No history of neurological or psychiatric diseases, no history of chronic illness
  • No positive results were found in the examination of the nervous system
  • All right-handed according to Edinburgh Handedness Inventory
  • The subjects voluntarily participated in this study and signed an informed consent form

You may not qualify if:

  • Individuals with severe illnesses
  • Previous history of brain surgery or epilepsy
  • Individuals who experience changes in physical condition during the experiment
  • Individuals with metal implants, such as pacemakers, DBS therapists, stents, etc
  • Alcoholics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

RECRUITING

Central Study Contacts

Yuan Xing, PhD, MD

CONTACT

Nan Zhang, PhD, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending, Department of Neurology, Principal Investigator

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 10, 2023

Study Start

June 1, 2023

Primary Completion

November 30, 2023

Study Completion

March 15, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations