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NCT07498270
Location- and Frequency-Dependent Effects of Thalamic Temporal Interference Stimulation During Sleep
Conditions: Healthy Adult Participants, Healthy Participants
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 24
Sponsor: University of Wisconsin, Madison
Location: Wisconsin Institute for Sleep and Consciousness Madison Wisconsin
Summary
This study is to find out whether a type of non-invasive electrical brain stimulation called temporal interference transcranial electrical stimulation (TI-TES) can temporarily change brain activity during sleep, especially sleep spindles (brain rhythms in the \~8-16 Hz range). Up to 24 healthy participants in Dane County, Wisconsin will be enrolled for 3 overnight study visits. Participants can expect to be on study for approximately 5 weeks, depending on scheduling availability.
Eligibility Criteria
Inclusion Criteria:
* Medically healthy (based on self-report and study team review)
* U.S. citizen or holding permanent resident status
* English-speaking (able to provide consent and complete questionnaires)
Exclusion Criteria:
* Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified in first MRI)
* History of inpatient psychiatric hospitalization
* History of head trauma resulting in prolonged loss of consciousness; or a history of greater than 3 grade I concussions
* Current history of poorly controlled headaches including intractable or poorly controlled migraines
* Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
* Possible pregnancy or plan to become pregnant in the next 6 months (self reported)
* Any metal in the head
* Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)
* Dental implants
* Permanent retainers
* Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions
* Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions
* Any medication that may alter seizure threshold taken during the study i.e., ADHD stimulants (Adderall, amphetamine); Tricyclic/atypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, bupropion); SSRIs (Escitalopram, Fluoxetine, Sertraline); Antipsychotics (chlorpromazine, clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); OTC antihistamines (diphenhydramine, Benadryl)
* Claustrophobia (a fear of small or closed places)
* Back problems that would prevent lying flat for up to two hours
* Regular night-shift work (second or third shift)
* Sleep apnea or other sleep disorder (self-reported)
Source: ClinicalTrials.gov (NCT07498270). StuddyBuddy aggregates publicly available trial information.