Transcranial Alternating Current StimulationGAMMAtACSNCT05809076
Effects of Gamma-tACS on EEG Periodic Activity
A study testing real tACS in people with Transcranial Alternating Current Stimulation, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial summary
In this study on healthy subjects, the effect of transcranial alternating current stimulation (tACS) will be investigated. In particular, the distinction between periodic and aperiodic electroencephalogram (EEG) activity will be considered, as well as the state-dependency phenomenon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transcranial Alternating Current Stimulation
- What is being tested?
- real tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jul 2021to 18 Jan 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- Common exclusion criteria
- Left-handedness (assessed through the Oldfield test)
- Diagnosis of neurological or psychiatric disorders
- Vision problems that prevent reading, not correctable with lenses
- Diagnosis of substance dependence on drugs or alcohol
- Presence of hearing aids/prostheses
Show all 20Show fewer
- Diagnosis of epilepsy or family history up to the second degree with it
- Episodes of febrile convulsions or recurrent fainting
- Head trauma
- Presence of surgical clips or metal implants in the head
- Diagnosis of heart disease
- Presence of a cardiac pacemaker or artificial heart valve
- Presence of hearing aids/prostheses
- Hearing problems or tinnitus
- Vision problems not corrected with lenses (such as color blindness)
- Taking tricyclic antidepressant medications
- Taking neuroleptic medications
- Diagnosis of headache or migraine
- Taking more than 3 alcoholic units in the last 24 hours
- Taking 2 or more cups of coffee or caffeine from other sources in the last 2 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Gamma-tACS on the Periodic Activity of Neural Signals as a Function of State-dependency
In this study on healthy subjects, the effect of transcranial alternating current stimulation (tACS) will be investigated. In particular, the distinction between periodic and aperiodic electroencephalogram (EEG) activity will be considered, as well as the state-dependency phenomenon. Participants will take part in two experimental sessions that will include tACS stimulation (one real, one control). Before, during, and after stimulation, subjects will have their EEG recorded during rest or during tasks.
The aim of this study is to investigate how the modulatory effects of gamma-tACS interact with intrinsic neural activity, measured in terms of periodic and aperiodic activity, as well as neurophysiological and behavioral modulation, taking into consideration the state-dependency phenomenon, which refers to the brain's activation state prior to stimulation.
- Being tested
- real tACS, sham tACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real tACSDevice
tACS is a non-invasive method to induce brain modulation. It will be applied at a frequency of 40 Hz (gamma-tACS) with a peak-to-peak intensity of 2 mA. During the real tACS condition, the alternating current will be administered for 20 minutes.
sham tACSDevice
In the sham tACS condition, the current will be delivered only for the first 30 seconds and then stopped, in order to simulate the same somatosensory sensations as real tACS, but without inducing modulation.
| Study group | Role | What they receive |
|---|---|---|
| real tACS | Experimental | Not described Receives: Device: real tACS |
| sham tACS | Sham comparator | Not described Receives: Device: sham tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting-state electroencephalography (EEG) signal
The periodic and aperiodic activity of the EEG signal will be estimated through Brainstorm (i.e., EEG analysis software) and quantified in terms of numerical values representing the periodic/aperiodic component of the EEG signal. The periodic and aperiodic activity of the EEG signal will be assessed during three time frames: baseline, during the intervention, and immediately after the intervention (real or sham tACS)
Measured: baseline
resting-state electroencephalography (EEG) signal
The periodic and aperiodic activity of the EEG signal will be estimated through Brainstorm (i.e., EEG analysis software) and quantified in terms of numerical values representing the periodic/aperiodic component of the EEG signal. The periodic and aperiodic activity of the EEG signal will be assessed during three time frames: baseline, during the intervention, and immediately after the intervention (real or sham tACS)
Measured: during the intervension
resting-state electroencephalography (EEG) signal
The periodic and aperiodic activity of the EEG signal will be estimated through Brainstorm (i.e., EEG analysis software) and quantified in terms of numerical values representing the periodic/aperiodic component of the EEG signal. The periodic and aperiodic activity of the EEG signal will be assessed during three time frames: baseline, during the intervention, and immediately after the intervention (real or sham tACS)
Measured: immediately after the intervention
Secondary outcomes (6)
behavioral performance (response times)
Participants' motor performance at a computerized task will be measured in terms of response times (how fast the participants press a computer button, according to the task's instructions). The participants' motor performance will be assessed during two time frames: baseline and immediately after the intervention (real or sham tACS)
Measured: baseline
behavioral performance (response times)
Participants' motor performance at a computerized task will be measured in terms of response times (how fast the participants press a computer button, according to the task's instructions). The participants' motor performance will be assessed during two time frames: baseline and immediately after the intervention (real or sham tACS)
Measured: immediately after the intervention
behavioral performance (accuracy)
Participants' motor performance at a computerized task will be measured in terms of accuracy (% of correct responses at the computerized task, according to the task's instructions). The participants' motor performance will be assessed during two time frames: baseline and immediately after the intervention (real or sham tACS)
Measured: baseline
behavioral performance (accuracy)
Participants' motor performance at a computerized task will be measured in terms of accuracy (% of correct responses at the computerized task, according to the task's instructions). The participants' motor performance will be assessed during two time frames: baseline and immediately after the intervention (real or sham tACS)
Measured: immediately after the intervention
auditory steady state response (ASSR)
The auditory steady state response will be measured via EEG during entrainment through exposure to amplitude-modulated 40Hz sounds (5 min, sequence of amplitude-modulated tones at 40 Hz, delivered via earplug binaurally). The auditory steady state response will be measured as power of the EEG gamma band. The auditory steady state response will be assessed during two time frames: baseline and immediately after the intervention (real or sham tACS)
Measured: baseline
auditory steady state response (ASSR)
The auditory steady state response will be measured via EEG during entrainment through exposure to amplitude-modulated 40Hz sounds (5 min, sequence of amplitude-modulated tones at 40 Hz, delivered via earplug binaurally). The auditory steady state response will be measured as power of the EEG gamma band. The auditory steady state response will be assessed during two time frames: baseline and immediately after the intervention (real or sham tACS)
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start20 Jul 2021
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Alternating 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arcara, Principal investigator, IRCCS San Camillo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809076
- Sponsor's protocol ID
- 2021.18
- Acronym
- GAMMAtACS
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Gamma-tACS on the Periodic Activity of Neural Signals as a Function of State-dependency
- ClinicalTrials.gov ID
- NCT05809076
- Acronym / sponsor ID
- GAMMAtACS / 2021.18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 12 Apr 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.
In this study on healthy subjects, the effect of transcranial alternating current stimulation (tACS) will be investigated. In particular, the distinction between periodic and aperiodic electroencephalogram (EEG) activity will be considered, as well as the state-dependency phenomenon. Participants will take part in two experimental sessions that will include tACS stimulation (one real, one control). Before, during, and after stimulation, subjects will have their EEG recorded during rest or during tasks.
The aim of this study is to investigate how the modulatory effects of gamma-tACS interact with intrinsic neural activity, measured in terms of periodic and aperiodic activity, as well as neurophysiological and behavioral modulation, taking into consideration the state-dependency phenomenon, which refers to the brain's activation state prior to stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tACS | Experimental | Device: real tACS |
| sham tACS | Sham comparator | Device: sham tACS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (20 listed)
- Common exclusion criteria
- Left-handedness (assessed through the Oldfield test)
- Diagnosis of neurological or psychiatric disorders
- Vision problems that prevent reading, not correctable with lenses
- Diagnosis of substance dependence on drugs or alcohol
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 |
|---|---|---|
| real tACStACS is a non-invasive method to induce brain modulation. It will be applied at a frequency of 40 Hz (gamma-tACS) with a peak-to-peak intensity of 2 mA. During the real tACS condition, the alternating current will be administered for 20 minutes. | Device | real tACS |
| sham tACSIn the sham tACS condition, the current will be delivered only for the first 30 seconds and then stopped, in order to simulate the same somatosensory sensations as real tACS, but without inducing modulation. | Device | sham tACS |
Primary outcome
resting-state electroencephalography (EEG) signal
Time frame: baseline
The periodic and aperiodic activity of the EEG signal will be estimated through Brainstorm (i.e., EEG analysis software) and quantified in terms of numerical values representing the periodic/aperiodic component of the EEG signal. The periodic and aperiodic activity of the EEG signal will be assessed during three time frames: baseline, during the intervention, and immediately after the intervention (real or sham tACS)
resting-state electroencephalography (EEG) signal
Time frame: during the intervension
The periodic and aperiodic activity of the EEG signal will be estimated through Brainstorm (i.e., EEG analysis software) and quantified in terms of numerical values representing the periodic/aperiodic component of the EEG signal. The periodic and aperiodic activity of the EEG signal will be assessed during three time frames: baseline, during the intervention, and immediately after the intervention (real or sham tACS)
resting-state electroencephalography (EEG) signal
Time frame: immediately after the intervention
The periodic and aperiodic activity of the EEG signal will be estimated through Brainstorm (i.e., EEG analysis software) and quantified in terms of numerical values representing the periodic/aperiodic component of the EEG signal. The periodic and aperiodic activity of the EEG signal will be assessed during three time frames: baseline, during the intervention, and immediately after the intervention (real or sham tACS)
6 secondary outcomes
behavioral performance (response times)
Time frame: baseline
behavioral performance (response times)
Time frame: immediately after the intervention
behavioral performance (accuracy)
Time frame: baseline
behavioral performance (accuracy)
Time frame: immediately after the intervention
auditory steady state response (ASSR)
Time frame: baseline
auditory steady state response (ASSR)
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Transcranial Alternating Current Stimulation
Recruiting
Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training in Alzheimer's Disease
Transcranial Alternating Current Stimulation, Alzheimer Disease (AD)
Recruiting
Transcranial Alternating Current Stimulation in Lewy Body Dementia
Lewy Body Dementia (LBD), Transcranial Alternating Current Stimulation
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Recruiting
Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression
Antenatal Depression
Active, not recruiting
Comparative Effects of Sensorimotor Training and tACS on Upper Limb Function and Cervical Proprioception in Subacute Stroke
Sub-acute Stroke
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.
Arcara principal investigator
IRCCS San Camillo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real tACS in people with Transcranial Alternating Current Stimulation, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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 1 inclusion and 20 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: finished, as of the sponsor's last update on 12 Apr 2023. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting-state electroencephalography (EEG) signal (time frame: baseline). The study lists 3 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 12 Apr 2023.