Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls

NCT07680114 | Not Yet Recruiting DMC FDA Device

• 3 other identifiers: 2026-0751Protocol Version 1SMPH | Psychiatry
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study to find out 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-especially sleep spindles (brain rhythms in the \~8-16 Hz range). The investigators are focusing on the thalamus, a deep brain region that helps coordinate brain activity during non-REM sleep. Sleep spindles are often reduced in schizophrenia, so this study is to see whether TES-TI can change spindle activity in individuals with schizophrenia spectrum disorders (SSD) and in healthy adults. To study this, a structural MRI scan will be used to customize where the stimulation electrodes are placed, and then TES-TI will be applied during one of two overnight sleep lab visits while brain activity is recorded with high-density EEG and standard sleep sensors. The other overnight is a baseline/control night during which only sham stimulation is delivered. The goal is to determine whether TES-TI during sleep can increase spindle-frequency activity in this population.

Conditions

Schizophrenia

Keywords

schizophrenia spectrum disorders; sleep spindles; transcranial electrical stimulation with temporal interference

Outcome Measures

Primary Outcomes (5)

• 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 density

  8-16 Hz spectral power

  data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep

• Change in spindle amplitude

  8-16 Hz spectral power

  data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep

• Change in spindle duration

  8-16 Hz spectral power

  data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep

• Change in spindle topography

  8-16 Hz spectral power

  data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep

Study Arms (2)

Participants with SSD

EXPERIMENTAL

Device: TES-TI; Device: Sham TES-TI

Healthy Controls

EXPERIMENTAL

Device: TES-TI; Device: Sham TES-TI

Interventions

TES-TI DEVICE

During the stimulation night, TES-TI will be delivered during stable N2 sleep in 3-minute epochs separated by 6-minute intervals, with up to 20 protocols per night, using randomized 10 Hz, 14 Hz, and carrier-only control conditions under continuous sleep-technician monitoring.

Also known as: transcranial electrical stimulation with temporal interference

Healthy Controls; Participants with SSD

Sham TES-TI DEVICE

ramp-sham stimulation only

Healthy Controls; Participants with SSD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Alkermes, Inc.: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Larissa Albantakis, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ONSETS Study

CONTACT

608-263-4313; onsets@psychiatry.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an experimental study using a within-subject, randomized, counterbalanced crossover design in which each participant serves as their own control.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 2, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-06

Locations

US (1)