Overnight Brain Stimulation for Sleep in Schizophrenia
This study is looking into whether a type of non-invasive electrical brain stimulation called transcranial electrical stimulation with temporal interference (TES-TI) can temporarily change brain activity during sleep. Specifically, it focuses on "sleep spindles" (brain rhythms in the 8-16 Hz range) in the thalamus, a deep brain region important for sleep. Sleep spindles are often reduced in people with schizophrenia. This study aims to see if TES-TI can increase these spindles in individuals with schizophrenia spectrum disorders (SSD) and in healthy adults. Success for this study means seeing a change in the amount, density, and strength of these sleep spindles after TES-TI. The study is currently unclear on its recruitment status and plans to enroll 20 participants.
- Study design
- This is a single-blind study, meaning you won't know if you're receiving the active stimulation or a sham (inactive) version. It involves 20 participants, including those with schizophrenia spectrum disorders and healthy controls.
- What's involved
- You would have an MRI scan, followed by two overnight visits for sleep monitoring and brain stimulation, separated by at least two weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Changes in sleep spindles will be measured during two overnight visits, separated by at least two weeks.
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NCT07680114
Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls
Recruiting
NAAges 18–50InterventionalBasic scienceUniversity of Wisconsin, MadisonInvestigator-initiated
~20 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:TES-TISham TES-TI
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in spindle-frequency activity (8-16 Hz spectral power)
Measured over data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
+4 more outcomes measured
Conditions
NCT07680114
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Wisconsin
Madison, Wisconsinno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Larissa Albantakis, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Eligibility criteria
Inclusion
U.S. citizen or holding permanent resident status
English-speaking
DSM-5 schizophrenia spectrum disorder (SSD) diagnosis, defined as schizophrenia, schizoaffective disorder, or schizophreniform disorder (confirmed by clinical interview and/or chart review)
Chronic illness, defined as diagnosis of SSD for at least 1 year
Clinically stable outpatient (no psychiatric hospitalization in past 6 months; no change in antipsychotic medication in the past 6 weeks)
Medically healthy (based on self-report and study team review)
Matched to SSD participants on age (±5 years) and sex
Exclusion
Current or past history of clinically significant neurological disorder or acquired neurological disease (e.g., stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified on the structural MRI)
Active suicidal ideation, plan, or intent (assessed via PHQ-9 item 9 and follow-up Columbia-Suicide Severity Rating Scale (C-SSRS) Screener; see Safety Response Procedure)
Inability to provide informed consent, including inadequate decisional capacity in the judgment of the study team and/or study psychiatrist
History of head trauma resulting in prolonged loss of consciousness; or a history of \>3 grade I concussions
Current poorly controlled headaches, including intractable or frequent 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
Current use of medications known to substantially lower seizure threshold, specifically chlorpromazine, clozapine, bupropion, clomipramine, or maprotiline; or other medications at doses known to substantially lower seizure threshold in the judgment of the PI or Study Psychiatrist
Current use of medications known to directly and substantially enhance sleep spindle activity, including benzodiazepines; non-benzodiazepine "Z-drug" hypnotics (zolpidem, eszopiclone, zaleplon); barbiturates; and gabapentin or pregabalin, within 2 weeks of the overnight study visits. Other sedating medications used as sleep aids (e.g., trazodone, hydroxyzine, mirtazapine) are permitted provided the regimen is stable across the two overnight visits; dose and timing will be recorded as covariates
Current moderate-to-severe alcohol or other substance use disorder (DSM-5) other than nicotine or caffeine
Active scalp lesions, broken skin, or skin conditions at planned electrode sites that would preclude safe electrode application
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)
Self-reported history of inpatient psychiatric hospitalization
Self-reported current or past diagnosis of schizophrenia or any other psychotic disorder
Self-reported first-degree relative with schizophrenia or any other psychotic disorder
Self-reported current or past diagnosis of bipolar disorder or major depressive disorder with psychotic features, or current treatment for any psychiatric disorder other than depression or anxiety (handled via the medication rule below)
Current use of any psychotropic medication, with the exception of a single SSRI or SNRI taken at a stable dose for at least 6 weeks for depression or anxiety. Current use of antipsychotics, tricyclic antidepressants, mirtazapine, trazodone, lithium or other mood stabilizers, benzodiazepines, non-benzodiazepine hypnotics, other anxiolytics, or stimulants will result in exclusion.
What this trial measures
- Change in spindle-frequency activity (8-16 Hz spectral power)data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
- Change in spindle densitydata collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
8-16 Hz spectral power
- Change in spindle amplitudedata collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
8-16 Hz spectral power
- Change in spindle durationdata collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
8-16 Hz spectral power
- Change in spindle topographydata collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
8-16 Hz spectral power