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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05923606
Other study ID # 2023P001479
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date August 31, 2026

Study information

Verified date March 2024
Source Massachusetts General Hospital
Contact Alexandra O'Neill, B.S.
Phone (617) 726-8753
Email agoneill@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will use novel transcranial alternating current stimulation (tACS) protocols and electroencephalography (EEG) to modulate and measure brain oscillations that underlie working memory. tACS is a noninvasive method used to modulate the timing and patterns of brain rhythms via weak electric currents passed through electrodes on the scalp.


Description:

In this study, healthy adult individuals will perform a spatial working memory task as investigators record scalp EEG before and immediately after undergoing transcranial alternating current stimulation (tACS). Each participant will complete four tACS sessions in randomized order: 1) theta-nested gamma tACS applied during active task periods, 2) theta-nested gamma tACS applied during passive (rest) periods, 3) gamma stimulation applied in phase with ongoing theta oscillations, and 4) placebo tACS. The different stimulation protocols will take place on different days. Therefore, participants will be expected to attend 4 in-person study visits at the Martinos Center for Biomedical Imaging in Charlestown, Massachusetts.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date August 31, 2026
Est. primary completion date August 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Able to provide informed consent - Fluent in English. Exclusion Criteria: - History of a neurological/psychiatric disorder - Current use of psychotropic medications - Current use of substances and drugs that were shown to affect tES (transcranial electrical stimulation) efficacy (dopamine altering drugs, nicotine, NMDA (N-methyl-D-aspartate) antagonists/agonists, sodium/calcium channel blockers, norepinephrine reuptake inhibitors, GABAergic modulators and selective serotonin reuptake inhibitors) - Contraindications for tACS (e.g., history of seizures, metallic implants in the head or neck, implanted brain stimulators, vagus nerve stimulators, pacemakers, pregnancy)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Active tACS
Active tACS will be administered over the left dorsolateral prefrontal cortex for approximately 25 minutes.
Placebo tACS
Placebo tACS will be administered over the left dorsolateral prefrontal cortex for approximately 25 minutes.

Locations

Country Name City State
United States Martinos Center for Biomedical Imaging Charlestown Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Working memory accuracy Accuracy of working memory retrieval during a Delayed Match-to-Sample task will be assessed before and during tACS interventions 2 hours
Primary Working memory accuracy under interference Accuracy of working memory retrieval during interference conditions of a Delayed Match-to-Sample task will be assessed before and during tACS interventions. 2 hours
Primary Theta-gamma cross-frequency coupling Cross-frequency coupling between theta band phase and gamma band amplitude will be calculated using the EEG data collected while subjects perform the Delayed Match-to-Sample task before and after tACS interventions. 2 hours
Primary Fronto-parietal theta phase synchronization Phase synchronization in the theta band between frontal and parietal brain regions will be calculated using the EEG data collected while subjects perform the Delayed Match-to-Sample task before and after the tACS interventions. 2 hours
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