Synchronization of Theta to Influence Memory | NCT07468279

NCT07468279

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sham Stimulation	Sham Comparator	Participants will be randomized to receive an active STARSTIM treatment or sham treatment.	Device: Sham device
STARSTIM device treatment (in-phase theta)	Experimental	Participants will be randomized to receive an active STARSTIM treatment or sham treatment.	Device: STARSTIM Device in-phase
STARSTIM device treatment (anti-phase stimulation)	Experimental	Participants will be randomized to receive an active STARSTIM treatment or sham treatment.	Device: STARSTIM Device anti-phase

Name	Type	Description	Arm Group Labels	Other Names
Sham device	Device	Intervention which uses an inactive form of stimulation via electrodes on the scalp.	Sham Stimulation

Measure	Description	Time Frame
The Difference Between Incidental Memory of Faces on Error versus Correct Trials from Baseline to Post Brain Stimulation	The hit rate for faces that appeared on error trials minus the hit rate for faces that appeared on correct trials.	Baseline through study visit completion, a maximum of 3 hours

Eligibility Module

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.