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

ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Sham TES-TI

    Device

    ramp-sham stimulation only

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Participants with SSDExperimental treatment 2 interventions
Group B: Healthy ControlsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in spindle-frequency activity (8-16 Hz spectral power)

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

Change in spindle density

8-16 Hz spectral power

Time frame
data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
3

Change in spindle amplitude

8-16 Hz spectral power

Time frame
data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep
4

Change in spindle duration

8-16 Hz spectral power

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.