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Recruiting NCT05580211

Neuromodulation for Schizophrenia

No phase Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-invasive brainstem modulation device (stimulation Randomized), Non-invasive brainstem modulation device (stimulation-Open Label).
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia

Overview

Our proposed study employs a novel approach to determine the clinical and functional imaging effects of brainstem neuromodulation, with an investigational study device, on illness awareness in schizophrenia - a significant contributor to medication non-adherence and poor treatment outcomes, and arguably the most treatment resistant manifestation of the disorder. The study device under investigation provides a safe and non-invasive method of brainstem stimulation that will be used in conjunction with a neuroimaging biomarker to measure brain changes associated with treatment and illness awareness.

Interventions

  • Device Non-invasive brainstem modulation device (stimulation Randomized)
    Study participants will receive \~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.
  • Device Non-invasive brainstem modulation device (stimulation-Open Label)
    Study participants will receive \~19-minute treatments twice daily in the clinic setting over 8 weeks using a non-invasive brainstem modulation device.

Primary outcome measures

  • Illness Awareness [Time frame: 4 weeks from baseline to end of treatment]
Secondary outcome measures (1)
  • Examine changes in brain network activity [Time frame: 4 weeks from baseline to end of treatment]

Eligibility criteria

Inclusion criteria

  • Male or female inpatients or outpatients ≥ 18 years of age
  • Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder
  • Voluntary and capable of consenting to participation in the research study
  • Fluent in English
  • Moderate-to-severe lack of illness awareness ≤7 on the VAGUS-SR, which corresponds to a rating of ≥3 on PANSS G12 Insight and Judgment item
  • On a stable dose of antipsychotic and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study

Exclusion criteria

  • Unwilling or unable to consent to the study
  • Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
  • Had eye surgery within the previous three (3) months
  • Ear surgery within 6 months prior to entering the study
  • Active ear infection or perforated tympanic membrane
  • Diagnosis of vestibular dysfunction
  • Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures
  • Acute suicidal and/or homicidal ideation
  • Formal thought disorder rating ≥4 on PANSS item P2
  • DSM-V substance dependence (except caffeine and nicotine) within one month prior to entering the study
  • Positive urine drug screen at the screening visit
  • Metal implants or a pacemaker that would preclude the MRI scan
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre for Addiction and Mental Health — Toronto

Identifiers

NCT: NCT05580211 · SNS-SCZ-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗