RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "After screening, consent, and clinical interview for individuals with SSD, participants will complete an MRI visit (T1, T2, DWI, and 10 min resting-state fMRI) for individualized montage optimization and two overnight hdEEG/PSG sessions in randomized, counterbalanced order, separated by at least two weeks: one baseline/control night with ramp-sham stimulation only, and one stimulation night."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether gentle electrical brain stimulation during sleep can increase sleep spindles, which are short bursts of brain activity. It is for adults with schizophrenia or related disorders and healthy adults. Participants have an MRI brain scan and two overnight sleep lab visits, one with real stimulation and one with sham stimulation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be a U.S. citizen or permanent resident and speak English.
  • For the patient group: You must have a confirmed diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.
  • For the patient group: You must have had the disorder for at least 1 year.
  • For the patient group: Your condition must be stable, with no mental health hospital stay in 6 months and no change in antipsychotic medicine in 6 weeks.
  • For the healthy group: You must be medically healthy and match a patient participant’s sex and age within 5 years.

Who can't join

  • Serious brain or nerve illness, major head injury, more than 3 mild concussions, or poorly controlled headaches. Seizures, certain abnormal brain-wave tests, or a family history of hard-to-treat epilepsy may also rule you out; a single seizure with a harmless cause may be allowed after specialist review.
  • Current thoughts or plans of suicide; inability to understand and agree to the study; or a current moderate or severe alcohol or drug use disorder, other than nicotine or caffeine.
  • An unstable illness that could cause an emergency during a seizure, possible pregnancy, or plans to become pregnant within 6 months.
  • Metal in the head, medical devices or implants, dental implants, or permanent retainers. Hair styles, hair pieces, or head coverings that cannot be removed for visits also rule you out.
  • Certain medicines that raise seizure risk or increase sleep spindles are not allowed. These include some mental health medicines and sleep medicines, plus gabapentin and pregabalin. The study team will review your medicines and when you take them.
  • Scalp sores or skin problems where electrodes would go; fear of closed spaces; or back problems that prevent lying flat for up to 2 hours.
  • Regular second- or third-shift work, sleep apnea, or another sleep disorder.
  • For healthy volunteers: A past mental health hospital stay; a personal history or close family history (parent, sibling, or child) of a psychotic disorder; bipolar disorder; or major depression with psychotic symptoms. Treatment for mental health conditions other than depression or anxiety also rules you out. Mental health medicines are not allowed except one SSRI or SNRI antidepressant at a stable dose for at least 6 weeks for depression or anxiety.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

WI