Clinical trial Recruiting at 1 site Interventional Ages 18 to 50

Overnight thalamic TES-TI to modulate sleep spindles in schizophrenia and matched healthy controls

Official title: A Pilot Feasibility Study of Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls

Run by University of Wisconsin, Madison · NCT07680114 · Data updated 2026-11-12

This study tests whether a noninvasive brain stimulation method during sleep can change sleep spindles in people with schizophrenia spectrum disorders and in healthy adults.

Quick facts

Study typeInterventional
Ages18 Years to 50 Years
SexAll
Enrollment20 (estimated)
SponsorUniversity of Wisconsin, Madison
Academic / other
Locations1 site (Madison, Wisconsin)
StatusRecruiting
StartedOctober 2026
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedOctober 1, 2026
Trial IDNCT07680114 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with schizophrenia spectrum disorders or healthy controls matched by age and sex, with MRI suitability and stable clinical status.

Probably not a fit

Patients not showing spindle modulation or not meeting sleep or imaging eligibility may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-site, single-blind, proof-of-concept study using transcranial electrical stimulation with temporal interference (TES-TI) during overnight sleep. Electrodes are placed using an MRI-guided personalized montage to target the thalamus while participants sleep, and brain activity is recorded with high-density EEG and standard sleep sensors. Each participant undergoes two overnight sessions: a baseline night with sham stimulation and a stimulation night, separated by at least two weeks. Primary outcomes look at spindle-frequency activity during stable N2 sleep, with exploratory analyses comparing baseline deficits and responsiveness across groups and linking changes to cognitive performance.

Why it matters

Potential benefit: If successful, TES-TI could provide a noninvasive way to influence sleep-related brain activity in schizophrenia.

How similar studies have gone: Prior noninvasive brain stimulation studies have shown feasibility in modulating sleep-related brain activity, but this specific TES-TI approach is exploratory and novel in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria (all participants):

* U.S. citizen or holding permanent resident status
* English-speaking

Inclusion Criteria (Participants with SSD):

* 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)

Inclusion Criteria (Healthy Controls):

* Medically healthy (based on self-report and study team review)
* Matched to SSD participants on age (±5 years) and sex

Exclusion Criteria (all participants):

* 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)

Exclusion Criteria (Healthy Controls):

* 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.

Where it's running

  • University of Wisconsin
    Madison, Wisconsin, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.