Effects of Gamma-tACS on EEG Periodic Activity

NCT05809076 | Completed

• 1 other identifier: 2021.18
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Transcranial Alternating Current Stimulation

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  immediately after the intervention

Secondary Outcomes (6)

• behavioral performance (response times)

  baseline

• behavioral performance (response times)

  immediately after the intervention

• behavioral performance (accuracy)

  baseline

• behavioral performance (accuracy)

  immediately after the intervention

• auditory steady state response (ASSR)

  baseline

Study Arms (2)

real tACS

EXPERIMENTAL

Device: real tACS

sham tACS

SHAM COMPARATOR

Device: sham tACS

Interventions

real tACS DEVICE

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.

real tACS

sham tACS DEVICE

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.

sham tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Healthy adults

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS San Camillo Hospital

Venice, Italy

Location

Study Officials

• Arcara

  IRCCS San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 12, 2023
• Study Start: July 20, 2021
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)