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Neuromodulation
Neuromodulation for Schizophrenia
N/A
Recruiting
Research Sponsored by Scion NeuroStim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks from baseline to end of treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate a new way to treat schizophrenia by stimulating the brain and using imaging to measure the effects.
Who is the study for?
This trial is for adults over 18 with schizophrenia or schizoaffective disorder, who have trouble recognizing their illness. They must speak English, be on stable medication for two months, and able to consent. Excluded are those with recent eye surgery, ear infections, substance dependence (except caffeine/nicotine), metal implants/pacemakers affecting MRI scans, pregnancy, vestibular dysfunction, severe medical conditions or thought disorders.
What is being tested?
The study tests a non-invasive brainstem modulation device's effect on illness awareness in schizophrenia patients. It involves safe brain stimulation alongside neuroimaging to track changes in the brain related to treatment response and recognition of the illness.
What are the potential side effects?
While specific side effects aren't listed here as it's investigational and non-invasive stimulation is generally considered safe; potential risks may include discomfort at the stimulation site or temporary hearing issues due to proximity to the ear.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks from baseline to end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks from baseline to end of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Illness Awareness
Secondary study objectives
Examine changes in brain network activity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Investigational Stimulation Pattern-Open LabelExperimental Treatment1 Intervention
Group II: Investigational Stimulation Pattern 2-RandomizedExperimental Treatment1 Intervention
Group III: Investigational Stimulation Pattern 1-RandomizedExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthOTHER
375 Previous Clinical Trials
82,853 Total Patients Enrolled
59 Trials studying Schizophrenia
4,277 Patients Enrolled for Schizophrenia
Scion NeuroStimLead Sponsor
13 Previous Clinical Trials
621 Total Patients Enrolled
1 Trials studying Schizophrenia
34 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use hearing aids or have chronic ear problems.I currently have an ear infection or a ruptured eardrum.I have been diagnosed with a balance disorder.I am willing and able to agree to participate in this study.I have not had eye surgery in the last 3 months.I do not have any major illnesses like heart disease or seizures.I am 18 years old or older.I have not had ear surgery in the last 6 months.I have been diagnosed with schizophrenia or schizoaffective disorder.I've been on a steady dose of my psychiatric medication for 2+ months.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Stimulation Pattern 1-Randomized
- Group 2: Investigational Stimulation Pattern 2-Randomized
- Group 3: Investigational Stimulation Pattern-Open Label
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.