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Recruiting NCT07468279

Synchronization of Theta to Influence Memory

No phase Interventional Cognitive Control Memory

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sham device, STARSTIM Device in-phase, STARSTIM Device anti-phase.
Who it may be relevant to
Registry conditions: Cognitive Control, Memory. Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Non-Invasive Brain Stimulation on Task Performance

Overview

This study aims to clarify relations between brain oscillations and two cognitive functions: cognitive control and memory.

Interventions

  • Device Sham device
    Intervention which uses an inactive form of stimulation via electrodes on the scalp.
  • Device STARSTIM Device in-phase
    Intervention that uses the Starstim tES device to introduce transcranial alternating current stimulation (tACS) in the form of in-phase theta (\~3.5 to \~7.5 Hz) via electrodes on the scalp.
  • Device STARSTIM Device anti-phase
    Intervention that uses the Starstim tES device to introduce transcranial alternating current stimulation (tACS) in the form of anti-phase stimulation via electrodes on the scalp.

Primary outcome measures

  • The Difference Between Incidental Memory of Faces on Error versus Correct Trials from Baseline to Post Brain Stimulation [Time frame: Baseline through study visit completion, a maximum of 3 hours]

Eligibility criteria

Inclusion criteria

  • 18 years and older
  • Fluent in English
  • Normal or corrected-to-normal vision
  • Willing to be photographed

Exclusion criteria

  • Must not have ever had an injury to the head that's caused you to be knocked out for a period of time (e.g., from a fall, blow to the head, road traffic accident).
  • Must not have an uncorrected vision or physical disability that interferes with your ability to see stimuli presented briefly on a computer screen or click a mouse button rapidly.
  • Must not have a history of epilepsy, convulsions, or seizures (except childhood febrile seizures).
  • Must not have a history of fainting or syncope.
  • For female participants, they must not be pregnant and/or must not think they might be pregnant.
  • Must not have skin problems like eczema, dermatitis, or open wounds on the scalp.
  • Must not have had prior brain surgery.
  • Must not have any metal located in the head/neck (except for dental fillings).
  • Must not have any devices or other implants located in/near their head. This includes cochlear implants and aneurysm clips, cardiac pacemaker, or any other implanted electronic device.
  • Must not have a current (active) alcohol or substance use disorder, must have no recent history of withdrawal symptoms, and must be able to safely abstain from alcohol and non-prescribed/illicit drugs for at least 24 hours before the session.
  • Must not have any alcohol on the day of the session, must limit alcohol consumption to no more than 2 drinks (if legally permitted) in the prior 24 hours, and must not use any non-prescribed or illicit drugs in the 24 hours before the session.
  • Must not be sick with a fever, sleep-deprived, or feel dizzy, unwell, or intoxicated.
  • Must also have eaten and had fluids but not have consumed more caffeine than they typically consume.
  • Must not be taking anticonvulsant/anti-epileptic drugs or have ever taken them within their lifetime.
  • Must not be taking benzodiazepines or have taken them within the past 3 months.
  • Must not have had a recent change (start, stop, dose change) for any psychiatric/psychotropic medications within the past 3 months.
  • Must not be taking Bupropion (Wellbutrin, Zyban), Tricyclic antidepressants (e.g., amitriptyline, imipramine, clomipramine, etc.), Antipsychotics (clozapine; chlorpromazine, haloperidol, etc.), or Tramadol or have taken them within the past 3 months.
  • Must not have experienced cardiac problems, fibrillation, or have taken medications associated with cardiac conditions within the past 3 months.
  • Must not meet the diagnostic threshold for Autism Spectrum Disorder, Intellectual Disability, or Psychotic Disorders.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Florida International University — Miami

Identifiers

NCT: NCT07468279 · IRB-25-0555

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗