Recruiting

Brainstem Neuromodulation

Sponsor:

Scion NeuroStim

Code:

NCT05580211

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-invasive brainstem modulation device (stimulation Randomized)

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

Study Details

Brief summary:

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.

Conditions

Schizophrenia

Study ID

NCT05580211

Start date

Oct 3, 2023

Status verified date

Dec, 2024

Completion date

Jan 30, 2026

Anticipated

Primary completion date

Oct 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female inpatients or outpatients ≥ 18 years of age
2. Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder
3. Voluntary and capable of consenting to participation in the research study
4. Fluent in English
5. 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
6. 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:

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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Investigational Stimulation Pattern 1-Randomized

other: Investigational Stimulation Pattern 2-Randomized

other: Investigational Stimulation Pattern-Open Label

Interventions

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.

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 measure

  • Illness Awareness [ Time Frame: 4 weeks from baseline to end of treatment ]

Central Contacts and Locations

Central contacts

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada

Contacts

More Information

Sponsor

Scion NeuroStim

Last update posted

Dec 17, 2024

Last verified

Dec, 2024

Keywords

  • neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scion NeuroStim on 2024-12-17.