20 Participants NeededMy employer runs this trial

TES-TI for Schizophrenia

(ONSETS Trial)

OS
Overseen ByONSETS Study
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
Must be taking: Antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new brain stimulation method called TES-TI (Transcranial Electrical Stimulation with Temporal Interference) to determine its effect on sleep rhythms in individuals with schizophrenia spectrum disorders (SSD) and healthy adults. Researchers aim to discover if this method can boost specific brain activities during sleep that are often diminished in people with SSD. Participants will spend two nights in a sleep lab, experiencing real stimulation on one night and fake stimulation on the other, to compare results. Individuals who have had schizophrenia, schizoaffective disorder, or schizophreniform disorder for at least a year and are stable on their medications may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve sleep quality for those with SSD.

Will I have to stop taking my current medications?

If you are taking medications that lower the seizure threshold or enhance sleep spindle activity, you may need to stop them before the study. Other medications, like certain sleep aids, are allowed if your dosage is stable. It's best to discuss your specific medications with the study team.

What prior data suggests that TES-TI is safe for individuals with schizophrenia spectrum disorders and healthy adults?

Research has shown that transcranial electrical stimulation with temporal interference (TES-TI) is generally safe for people. Studies have found that this non-surgical brain stimulation method is both safe and well-tolerated. For instance, one study demonstrated that TES-TI can safely target specific brain areas, such as the hippocampus, without causing harm. Another study highlighted that this technique can effectively provide deep brain stimulation without major side effects.

In summary, current research suggests that TES-TI is a safe and practical option for brain stimulation in humans.12345

Why are researchers excited about this trial?

Unlike the standard treatments for schizophrenia that mainly involve antipsychotic medications targeting dopamine receptors, TES-TI is unique because it uses a non-invasive brain stimulation technique. This method, known as Transcranial Electrical Stimulation with Temporal Interference, is designed to target specific brain regions without affecting others, potentially reducing side effects. Researchers are excited about TES-TI because it offers a new way to modulate brain activity directly and could lead to faster and more targeted improvements in symptoms.

What evidence suggests that TES-TI is effective for schizophrenia?

Research has shown that transcranial electrical stimulation with temporal interference (TES-TI) can improve thinking skills in people with schizophrenia. Studies have found significant enhancements in mental abilities and a reduction in negative symptoms. Specifically, patients experienced a 41.8% increase in cognitive scores, including improved visual and verbal learning. In this trial, participants with schizophrenia spectrum disorders (SSD) will receive TES-TI to assess its effectiveness. TES-TI can safely reach deep brain areas and may alleviate symptoms like lack of motivation. These findings suggest that TES-TI could be a promising method to enhance brain function in schizophrenia.12345

Who Is on the Research Team?

LA

Larissa Albantakis, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for adults with schizophrenia spectrum disorders and healthy individuals matched by age and sex. Participants must be able to safely undergo MRI scans, sleep overnight in a lab, and not have conditions or implants that make brain stimulation unsafe.

Inclusion Criteria

Healthy Controls must be medically healthy based on self-report and study team review
All participants must be U.S. citizens or hold permanent resident status
All participants must be English-speaking
See 4 more

Exclusion Criteria

All participants with possible pregnancy or plan to become pregnant in next 6 months
All participants with any metal in the head
All participants with permanent retainers
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Visit

Participants undergo an MRI visit for individualized montage optimization

1 day
1 visit (in-person)

Overnight Sleep Lab Visits

Participants complete two overnight hdEEG/PSG sessions with TES-TI stimulation and sham control

2 overnight visits separated by at least 2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for changes in spindle-frequency activity and cognitive performance

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Electrical Stimulation with Temporal Interference (TES-TI)

Trial Overview

The study tests whether a non-invasive electrical brain stimulation called TES-TI can change certain sleep-related brain rhythms (sleep spindles) during overnight sleep. Each participant receives both real TES-TI and sham (placebo) stimulation on separate nights.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Participants with SSDExperimental Treatment2 Interventions
Group II: Healthy ControlsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Alkermes, Inc.

Industry Sponsor

Trials
118
Recruited
27,200+

Richard Pops

Alkermes, Inc.

Chief Executive Officer since 1991

BA in Economics from Stanford University

Dr. Craig Hopkinson

Alkermes, Inc.

Chief Medical Officer since 2017

MD

Citations

Individualized transcranial temporal interference stimulation ...

Compared to baseline, patients showed marked improvements in cognitive function and reductions in negative symptoms [29].

Efficacy and Safety of Transcranial Temporal Interference ...

Results All 8 participants completed treatment. PANSS total scores decreased by 8.1% (baseline: 64.5 ± 14.8 vs follow-up: 59.3 ± 15.7; padj = ...

Efficacy and Safety of Transcranial Temporal Interference ...

MCCB total scores improved by 41.8% (baseline: 23.7 ± 10.4 vs follow-up: 33.6 ± 9.7, p adj < 0.001), with significant gains in visual and verbal learning (p adj ...

Non-invasive temporal interference electrical stimulation of ...

TI stimulation can focally modulate hippocampal activity and enhance the accuracy of episodic memories in healthy humans.

Temporal Interference Stimulation for Social Cognition

tIS may be useful in the treatment of social cognitive impairments in schizophrenia and especially in the reversal of oscillatory dysfunction ...