Synchronizing theta brain waves to influence memory
Effects of Non-Invasive Brain Stimulation on Task Performance
NA · Florida International University · NCT07468279
This study tests whether using a wearable device to synchronize theta brain waves can change memory and cognitive control in English‑speaking adults without prior brain injury.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Florida International University (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07468279 on ClinicalTrials.gov |
What this trial studies
Adults will receive short sessions of noninvasive electrical stimulation with a STARSTIM device in one of three conditions: in‑phase, anti‑phase, or sham. While stimulation is applied, participants will perform memory and cognitive control tasks and researchers will record brain activity to track theta oscillations. Sessions occur at Florida International University and include screening for safety exclusions such as prior head injury, seizures, implants, or scalp skin problems. The goal is to connect changes in theta synchrony with changes in task performance.
Who should consider this trial
Good fit: Adults 18 or older who are fluent in English, have normal or corrected vision, no history of head injury, seizures, brain surgery, metal or electronic implants in the head/neck, and no scalp skin conditions are eligible.
Not a fit: People with past head injuries that caused loss of consciousness, a history of seizures or fainting, metal or electronic implants in the head/neck, prior brain surgery, scalp skin problems, or pregnancy would not be expected to benefit and are excluded.
Why it matters
Potential benefit: If successful, this approach could point to a noninvasive way to modulate memory and cognitive control that might inform future therapies.
How similar studies have performed: Related noninvasive brain stimulation studies (including transcranial alternating current approaches) have shown mixed but sometimes promising effects on memory and cognitive control in previous research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- Florida International University — Miami, Florida, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cognitive Control, Memory