← Back to Search

Non-invasive Neuromodulation for Schizophrenia

N/A

Recruiting

Led By Philip Gerretsen, MD, PhD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder

Be older than 18 years old

Must not have

Active ear infection or perforated tympanic membrane

Diagnosis of vestibular dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up illness awareness will be assessed at pre-intervention and immediately following the intervention and weekly for up to 4 weeks post-intervention.

Summary

This trial will test if an experimental therapy (CVS) can improve illness awareness in schizophrenia patients, and track changes in brain network activity.

Who is the study for?

Adults diagnosed with schizophrenia or schizoaffective disorder, who have a moderate-to-severe lack of illness awareness and are stable on their current medications. Participants must be fluent in English, able to consent, and not planning medication changes during the study. Excluded are those with recent ear or eye surgery, active ear issues, severe medical conditions like heart disease or seizures, substance dependence (except caffeine/nicotine), pregnancy, vestibular dysfunction, metal implants/pacemakers affecting MRI scans.

What is being tested?

The trial is testing a non-invasive brainstem neuromodulation device to see if it can improve illness awareness in people with schizophrenia. It involves twice-daily sessions for four weeks and compares this treatment against a sham (fake) procedure. The effects will be measured through self-awareness assessments and brain imaging before and after the treatment period.

What are the potential side effects?

Potential side effects aren't specified but may include discomfort from wearing the device or reactions related to sensory organs due to its neuromodulatory nature. Since it's investigational, close monitoring for unexpected side effects is likely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I currently have an ear infection or a ruptured eardrum.

Select...

I have been diagnosed with a balance disorder.

Select...

I have not had eye surgery in the last 3 months.

Select...

I do not have any severe illnesses like heart disease or epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and post-intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and post-intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and post-intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Illness awareness

Secondary study objectives

Brain network activity

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Open LabelExperimental Treatment1 Intervention

After completion of sham or active stimulation over 4 weeks, participants can choose to receive \~18-minute active stimulation twice daily for up to 12 weeks.

Group II: Active TreatmentActive Control1 Intervention

Study participants will receive \~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation device.

Group III: Sham TreatmentPlacebo Group1 Intervention

Study participants will receive \~18-minute of sham stimulation twice daily over 4 weeks using a non-invasive brainstem modulation device.

0 / 5Eligibility criteria met