Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects

NCT06229002 | Recruiting

• 1 other identifier: 2023-A01368-37
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

stress. Notably, several studies reported that stress could alter impulsivity, source monitoring, and time perception. Several mechanisms are involved in the response to a stress factor, among them the hypothalamic-pituitary-adrenal (HPA) axis. The cortisol reactivity (it means the cortisol secretion after the exposure to a standardized stress factor) is a reliable tool to assess the function of HPA. Cortisol secretion is bidirectionally influenced by the prefrontal cortex (PFC), which is involved in the expression and regulation of stress as well. The asymmetry of the alpha band (AFα) is a well known electrophysiological parameter to assess the function of PFC. More precisely, AFα is arising a growing interest, as it is believed to be correlated with the cortisol reactivity. Modifying this asymmetry could influence the stress response. Transcranial Alternating Current Stimulation (tACS) consists in delivering a sinusoidal alternating current between two electrodes placed on the scalp at a predefined frequency. Previous studious reported that tACS, if delivered at the alpha frequency, increased the alpha band in the stimulated areas

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of the cortisol secretion after the stress task.

  Samples of salivary cortisol will be repeatedly (10 occurences) collected during the experiment. The collection will take place before, during and after the stress task.

  1 day

Secondary Outcomes (13)

• Effect of α-tACS on the cortisol awakening response in stressed healthy subjects

  4 days

• Effect of α-tACS on the molecular reactivity to stress

  1 day

• Effect of α-tACS on the molecular reactivity to stress

  1 day

• Effect of α-tACS on the molecular reactivity to stress

  1 day

• Effect of α-tACS on the molecular reactivity to stress

  1 day

Study Arms (2)

Active tACS stimulation

EXPERIMENTAL

Transcranial alternative current stimulation (tACS) at alpha frequency Single session of tACS : 30 minutes, 2mA, frequency = 10Hz, both electrodes located on the dorsolateral prefrontal cortex (left and right)

Procedure: Transcranial alternative current stimulation (tACS) at alpha frequency

Sham stimulation

PLACEBO COMPARATOR

Single session of tACS sham stimulation : both electrodes located on the dorsolateral prefrontal cortex (left and right) ; real current delivered for the first and last 30s of the total stimulation time (ramp-in and ramp-out)

Procedure: Sham stimulation

Interventions

Transcranial alternative current stimulation (tACS) at alpha frequency PROCEDURE

Single session of tACS

Active tACS stimulation

Sham stimulation PROCEDURE

Single session of tACS sham stimulation

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-handed Men and Women aged between 18 and 45
• If woman, hormonal contraception required
• Having given their written informed consent
• Affiliated with a social security scheme
• French speakers and readers

You may not qualify if:

• Contraindication to the exposure to exposure to tACS
• Current psychiatric disorder as classified in the DSM-5
• Regular intake of any psychotropic drug or Beta Blocker
• Recent exposure to a traumatic event
• Any debilitating condition making the experimental procedure not feasible
• Pregnancy

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, AURA, 69678 CEDEX, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and experimenters (including α-tACS operator) will not be informed about the nature (active or placebo) of the stimulation they will receive
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, randomized parallel arms study including 40 healthy participants who will receive active and placebo α-tACS

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 29, 2024
• Study Start: January 24, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 7, 2024

Record last verified: 2023-12

Locations

FR (1)