NCT05580211Recruiting
Neuromodulation for Schizophrenia
The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Source: ClinicalTrials.gov · Last updated 17 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 11 Oct 2022
- Start date
- 3 Oct 2023
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- Scion NeuroStim
- Diseases
- Schizophrenia
- NCT number
- NCT05580211
What you commit to
- Study type: Interventional
- Planned participants: 34
- From 3 Oct 2023 to the primary completion date, 30 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had eye surgery within the previous three (3) months
- Ear surgery within 6 months prior to entering the study
- Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures
- 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
Other illness
- Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
- Active ear infection or perforated tympanic membrane
- Formal thought disorder rating ≥4 on PANSS item P2
Other
- Unwilling or unable to consent to the study
- Diagnosis of vestibular dysfunction
- Acute suicidal and/or homicidal ideation
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.