Actively Recruiting
Neuromodulation for Schizophrenia
Led by Scion NeuroStim · Updated on 2024-12-17
34
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
S
Scion NeuroStim
Lead Sponsor
C
Centre for Addiction and Mental Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Neuromodulation for Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female inpatients or outpatients 18 years of age or older
- Diagnosed with schizophrenia or schizoaffective disorder according to DSM-V
- Able and willing to voluntarily consent to participate
- Fluent in English
- Moderate-to-severe lack of illness awareness (score 7 on VAGUS-SR or 3 on PANSS G12 Insight and Judgment item)
- On a stable dose of antipsychotic and other medications for at least 2 months with no expected dose changes during the study
You will not qualify if you...
- Unable or unwilling to provide consent
- Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
- Eye surgery within the past 3 months
- Ear surgery within the past 6 months
- Active ear infection or perforated eardrum
- Diagnosis of vestibular dysfunction
- Unstable medical illness or major medical or neurological illness including cardiovascular disease or seizures
- Acute suicidal or homicidal thoughts
- Severe formal thought disorder (PANSS P2 score 4)
- Substance dependence (except caffeine and nicotine) within 1 month prior to study
- Positive urine drug test at screening
- Metal implants or pacemaker incompatible with MRI
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Actively Recruiting
Research Team
P
Phillip Gerretson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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