Transcranial Direct Current StimulationNCT06076044
Effects of Transcranial Oscillatory Direct Current Stimulation on the Functions of Cerebral Cortex in Healthy Subjects
A study testing toDCS 2mA 1Hz, toDCS 2mA 10Hz and tDCS 1mA in people with Transcranial Direct Current Stimulation and Motor Evoked Potential, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Transcranial Direct Current Stimulation, Motor Evoked Potential, Healthy Subjects
- What is being tested?
- toDCS 2mA 1Hz, toDCS 2mA 10Hz and tDCS 1mA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
Yuan Xing, PhD, MD, +8618633888925, leaf_trunks@163.com
Nan Zhang, PhD, MD, +8618633888974, jlx88cn@163.com
About this study
To investigate the effect of transcranial oscillatory direct current stimulation on functions of cerebral cortex (cortical excitability and frequency of eeg) in healthy subjects
- Being tested
- toDCS 2mA 1Hz, toDCS 2mA 10Hz, tDCS 1mA, sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toDCS 2mA 1HzDevice
The subgroup treated by transcranial oscillatory direct current stimulation of 2mA and 1Hz.
toDCS 2mA 10HzDevice
The subgroup treated by transcranial oscillatory direct current stimulation of 2mA and 10Hz.
tDCS 1mADevice
The subgroup treated by transcranial direct current stimulation of 1mA.
shamDevice
The subgroup treated by sham stimulation.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Experimental | healthy male subjects aged 20-30 years Receives: Device: toDCS 2mA 1Hz; Device: toDCS 2mA 10Hz; Device: tDCS 1mA; Device: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEP
Motor evoked potentials of the right abductor pollicis brevis were collected
Measured: 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
Measured: before treatment and right after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jun 2023
- Primary completion30 Nov 2023
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Xing, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076044
- Sponsor's protocol ID
- FirstHebei
- Status last verified
- Feb 2024
- First submitted
- 21 Sep 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Oscillatory Direct Current Stimulation on the Functions of Cerebral Cortex in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06076044
- Acronym / sponsor ID
- FirstHebei
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of transcranial oscillatory direct current stimulation on functions of cerebral cortex (cortical excitability and frequency of eeg) in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | Experimental | Device: toDCS 2mA 1Hz, Device: toDCS 2mA 10Hz, Device: tDCS 1mA, Device: shamhealthy male subjects aged 20-30 years |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| toDCS 2mA 1HzThe subgroup treated by transcranial oscillatory direct current stimulation of 2mA and 1Hz. | Device | healthy subjects |
| toDCS 2mA 10HzThe subgroup treated by transcranial oscillatory direct current stimulation of 2mA and 10Hz. | Device | healthy subjects |
| tDCS 1mAThe subgroup treated by transcranial direct current stimulation of 1mA. | Device | healthy subjects |
| shamThe subgroup treated by sham stimulation. | Device | healthy subjects |
Primary outcome
MEP
Time frame: before treatment and 20, 30, 40, 50, 60 minutes after treatment
Motor evoked potentials of the right abductor pollicis brevis were collected
Power Spectral Density of EEG
Time frame: before treatment and right after treatment
The rest state EEG of the subjects was collected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing toDCS 2mA 1Hz, toDCS 2mA 10Hz and tDCS 1mA in people with Transcranial Direct Current Stimulation and Motor Evoked Potential, run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Xing, PhD, MD (+8618633888925, leaf_trunks@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEP (time frame: before treatment and 20, 30, 40, 50, 60 minutes after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.