Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05580211

Neuromodulation for Schizophrenia

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Location status: Recruiting

Location contact

Phillip Gerretson, MD

CONTACT

[email protected]

416-535-8501 ext. 39426

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive brainstem modulation device (stimulation Randomized)

Device

Study participants will receive ~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.

Non-invasive brainstem modulation device (stimulation-Open Label)

Device

Study participants will receive ~19-minute treatments twice daily in the clinic setting over 8 weeks using a non-invasive brainstem modulation device.

Primary outcomes

  1. Illness Awareness

    Time frame: 4 weeks from baseline to end of treatment

    functional MRI paradigm. The paradigm consists of a bank of brief questions or statements to which participants respond either "yes/agree" or "no/disagree". The brief statements are derived from four categories: general illness awareness, symptom awareness and attribution, awareness of need for treatment, and illness independent/control.

Secondary outcomes

  1. Examine changes in brain network activity

    Time frame: 4 weeks from baseline to end of treatment

    functional MRI blood oxygen level dependent (BOLD) in response to an illness awareness task pre- and post-treatment. This will serve as a biomarker to rigorously test whether repeated treatment engages the posterior parietal area of the brain associated with illness awareness.

Study contacts

Contact information is provided by the study sponsor or research team.

Phillip Gerretson, MD

CONTACT

[email protected]

416-535-8501 ext. 39426

Sponsors and collaborators

Lead sponsor

Scion NeuroStim

Industry

Collaborators

  • Centre for Addiction and Mental Health

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 14, 2022
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.