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

2026年8月27日 更新者:University of Wisconsin, Madison

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

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.

調査の概要

詳細な説明

This single-site, single-blind, proof-of-concept feasibility study will evaluate the feasibility of overnight thalamic transcranial electrical stimulation with temporal interference (TES-TI) to modulate sleep spindle activity during N2 sleep in individuals with schizophrenia spectrum disorders (SSD) and matched healthy controls (HC).

The study is investigational and is not designed or intended to provide therapeutic benefit; no treatment effect is claimed. 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. 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.

Primary physiological outcomes will assess changes in spindle-frequency activity and related spindle measures relative to baseline and carrier-only control. Exploratory analyses will compare baseline spindle deficits and TES-TI responsiveness across groups and examine whether stimulation-related changes are associated with cognitive performance, assessed using the Boston Cognitive Assessment (BoCA).

研究の種類

介入

入学 (推定)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Wisconsin
      • Madison、Wisconsin、アメリカ、53719
        • 募集
        • University of Wisconsin

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:健康管理
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.
他の名前:
  • transcranial electrical stimulation with temporal interference
ramp-sham stimulation only
実験的:Participants with SSD
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.
他の名前:
  • transcranial electrical stimulation with temporal interference
ramp-sham stimulation only

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in spindle-frequency activity (8-16 Hz spectral power)
時間枠:data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
Change in spindle density
時間枠:data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
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
時間枠:data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
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
時間枠:data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
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
時間枠:data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
8-16 Hz spectral power
data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

協力者

捜査官

  • 主任研究者:Larissa Albantakis, PhD、University of Wisconsin, Madison

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年6月25日

QC基準を満たした最初の提出物

2026年6月25日

最初の投稿 (実際)

2026年7月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月31日

QC基準を満たした最後の更新が送信されました

2026年8月27日

最終確認日

2026年8月1日

詳しくは

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米国FDA規制機器製品の研究

はい

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はい

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