Synchronization of Theta to Influence Memory (STIM)
Effects of Non-Invasive Brain Stimulation on Task Performance
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33199
- Recruiting
- Florida International University
-
Contact:
- George Buzzell
- Phone Number: 305-348-2868
- Email: gbuzzell@fiu.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 work i.e., braces, permanent retainers, etc.)
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Sham Comparator: Sham Stimulation
Participants will be randomized to receive an active STARSTIM treatment or sham treatment.
|
Intervention which uses an inactive form of stimulation via electrodes on the scalp.
|
|
Experimental: STARSTIM device treatment (in-phase theta)
Participants will be randomized to receive an active STARSTIM treatment or sham treatment.
|
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.
|
|
Experimental: STARSTIM device treatment (anti-phase stimulation)
Participants will be randomized to receive an active STARSTIM treatment or sham treatment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- IRB-25-0555
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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