Transcranial Alternating Current StimulationPhase 1/2AIRCRAFTNCT04560959
Atlas of Intracranial Recordings on Cortical Responses After Functional tACS
A Phase 1/2 study testing tACS in people with Transcranial Alternating Current Stimulation, run by Xuanwu Hospital, Beijing.
Trial summary
By analyzing the SEEG recordings, we explore the range of cortical functional responses to strings of 77.5Hz stimulations delivered by tACS, Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Transcranial Alternating Current Stimulation
- What is being tested?
- tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2020to 1 Dec 2021
- Phase
- Phase 1/2
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All epileptic patients that would receive the implantation of SEEG electrodes, regardless of the seizure locations;
- There was no metal implantation before;
- Eligible for MRI examination;
- No other lesional neurological disorders;
- Could be well informed by the study protocols.
Who cannot join
- Suffered from any other mental illnesses prior to the enrollment;
- Those suffering from the serious or unstable organic diseases;
- Pregnant or lactation women, and those who have a plan of pregnant;
- Patients with central nervous system tumors, acute brain injury or infection;
- Skin injured, or allergic to the exposure of the conductive gel;
- Those with implanted devices;
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- Those who received modified electrical convulsive therapy, or TMS within the recent one month;
- The score of item 3 (suicidal item) in HAMD-17 equal or greater than 3;
- Enrolled in any other on going trials;
- Other situations evaluated by the researchers as inappropriate to the enrollment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Atlas of Cerebral Responses to the Stimuli of the tACS Recorded by SEEG
By analyzing the SEEG recordings, we explore the range of cortical functional responses to strings of 77.5Hz stimulations delivered by tACS,
- Being tested
- tACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACSDevice
tACS would be performed to epilepsy patients who have already received implantation of the SEEG electrodes
| Study group | Role | What they receive |
|---|---|---|
| tACS arm | Experimental | The patient would receive strings of tACS stimulations in 77.5 HZ, each string would last for 1 second, followed by an interval of 5 seconds. A total of 600 strings would be sent out to the patients. Receives: Device: tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of intracranial activities
The change of the power in a band of 0-200 HZ according to the intracranial EEG recording.
Measured: Within 250 ms immediately after the stimulation.
Secondary outcomes (2)
Frequency of the epileptic discharges
To count the numbers of epileptic discharges within the same duration before and when tACS intervention.
Measured: 50 minutes during the stimulation and 50 minutes of the interictal baseline before the intervention during the same hour of the day
Event related potential (ERP)
ERP related to cognitive tasks before and immediately after the tACS intervention
Measured: Baseline: 24 hours before the tACS intervention; Observation: Immediately after the end of the tACS intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start20 Sep 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Alternating Current StimulationStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G.G. Zhao, Principal investigator, Department of Neurosurgery, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560959
- Sponsor's protocol ID
- LYS-[2020]-051
- Acronym
- AIRCRAFT
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Shan Y, Wang H, Yang Y, Wang J, Zhao W, Huang Y, Wang H, Han B, Pan N, Jin X, Fan X, Liu Y, Wang J, Wang C, Zhang H, Chen S, Liu T, Yan T, Si T, Yin L, Li X, Cosci F, Zhang X, Zhang G, Gao K, Zhao G. Evidence of a large current of transcranial alternating current stimulation directly to deep brain regions. Mol Psychiatry. 2023 Dec;28(12):5402-5410. doi: 10.1038/s41380-023-02150-8. Epub 2023 Jul 19.
PubMed 37468529
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Atlas of Cerebral Responses to the Stimuli of the tACS Recorded by SEEG
- ClinicalTrials.gov ID
- NCT04560959
- Acronym / sponsor ID
- AIRCRAFT / LYS-[2020]-051
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Sep 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 23 Sep 2020 (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.
By analyzing the SEEG recordings, we explore the range of cortical functional responses to strings of 77.5Hz stimulations delivered by tACS,
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tACS arm | Experimental | Device: tACSThe patient would receive strings of tACS stimulations in 77.5 HZ, each string would last for 1 second, followed by an interval of 5 seconds. A total of 600 strings would be sent out to the patients. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- All epileptic patients that would receive the implantation of SEEG electrodes, regardless of the seizure locations;
- There was no metal implantation before;
- Eligible for MRI examination;
- No other lesional neurological disorders;
- Could be well informed by the study protocols.
Key exclusion criteria (10 listed)
- Suffered from any other mental illnesses prior to the enrollment;
- Those suffering from the serious or unstable organic diseases;
- Pregnant or lactation women, and those who have a plan of pregnant;
- Patients with central nervous system tumors, acute brain injury or infection;
- Skin injured, or allergic to the exposure of the conductive gel;
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 |
|---|---|---|
| tACStACS would be performed to epilepsy patients who have already received implantation of the SEEG electrodes | Device | tACS arm |
Primary outcome
Changes of intracranial activities
Time frame: Within 250 ms immediately after the stimulation.
The change of the power in a band of 0-200 HZ according to the intracranial EEG recording.
2 secondary outcomes
Frequency of the epileptic discharges
Time frame: 50 minutes during the stimulation and 50 minutes of the interictal baseline before the intervention during the same hour of the day
Event related potential (ERP)
Time frame: Baseline: 24 hours before the tACS intervention; Observation: Immediately after the end of the tACS intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Derived from this study: PubMed 37468529Shan Y, Wang H, Yang Y, Wang J, Zhao W, Huang Y, Wang H, Han B, Pan N, Jin X, Fan X, Liu Y, Wang J, Wang C, Zhang H, Chen S, Liu T, Yan T, Si T, Yin L, Li X, Cosci F, Zhang X, Zhang G, Gao K, Zhao G. Evidence of a large current of transcranial alternating current stimulation directly to deep brain regions. Mol Psychiatry. 2023 Dec;28(12):5402-5410. doi: 10.1038/s41380-023-02150-8. Epub 2023 Jul 19.
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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.
G.G. Zhao principal investigator
Department of Neurosurgery, Capital Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tACS in people with Transcranial Alternating Current Stimulation, run by Xuanwu Hospital, Beijing.
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 5 inclusion and 10 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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 P.H. Wei (+86-010-83198252, weipenghu@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of intracranial activities (time frame: Within 250 ms immediately after the stimulation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560959, which also lists 1 linked publication.
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 Sep 2020.