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Non-invasive Neuromodulation for Schizophrenia
N/A
Recruiting
Led By Philip Gerretsen, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up illness awareness will be assessed at pre-intervention and immediately following the intervention and weekly for up to 4 weeks post-intervention.
Awards & highlights
Study Summary
This trial will test if an experimental therapy (CVS) can improve illness awareness in schizophrenia patients, and track changes in brain network activity.
Who is the study for?
Adults diagnosed with schizophrenia or schizoaffective disorder, who have a moderate-to-severe lack of illness awareness and are stable on their current medications. Participants must be fluent in English, able to consent, and not planning medication changes during the study. Excluded are those with recent ear or eye surgery, active ear issues, severe medical conditions like heart disease or seizures, substance dependence (except caffeine/nicotine), pregnancy, vestibular dysfunction, metal implants/pacemakers affecting MRI scans.Check my eligibility
What is being tested?
The trial is testing a non-invasive brainstem neuromodulation device to see if it can improve illness awareness in people with schizophrenia. It involves twice-daily sessions for four weeks and compares this treatment against a sham (fake) procedure. The effects will be measured through self-awareness assessments and brain imaging before and after the treatment period.See study design
What are the potential side effects?
Potential side effects aren't specified but may include discomfort from wearing the device or reactions related to sensory organs due to its neuromodulatory nature. Since it's investigational, close monitoring for unexpected side effects is likely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia or schizoaffective disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and post-intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and post-intervention.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Illness awareness
Secondary outcome measures
Brain network activity
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Open LabelExperimental Treatment1 Intervention
After completion of sham or active stimulation over 4 weeks, participants can choose to receive ~18-minute active stimulation twice daily for up to 12 weeks.
Group II: Active TreatmentActive Control1 Intervention
Study participants will receive ~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation device.
Group III: Sham TreatmentPlacebo Group1 Intervention
Study participants will receive ~18-minute of sham stimulation twice daily over 4 weeks using a non-invasive brainstem modulation device.
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Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,424 Total Patients Enrolled
58 Trials studying Schizophrenia
4,197 Patients Enrolled for Schizophrenia
Scion NeuroStimIndustry Sponsor
13 Previous Clinical Trials
696 Total Patients Enrolled
1 Trials studying Schizophrenia
34 Patients Enrolled for Schizophrenia
Philip Gerretsen, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
260 Total Patients Enrolled
4 Trials studying Schizophrenia
200 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a balance disorder.I currently have an ear infection or a ruptured eardrum.I am willing and able to agree to participate in this study.I've been on a steady dose of my psychiatric medication for 2 months.I have not had eye surgery in the last 3 months.You have tested positive for drugs in your urine at the screening visit.You have metal implants or a pacemaker that would prevent you from having an MRI scan.I have not had ear surgery in the last 6 months.You use hearing aids or cochlear implants, or have ongoing ringing in your ears, or have issues with your jaw joint.I do not have any severe illnesses like heart disease or epilepsy.You are having thoughts about hurting yourself or someone else right now.I have been diagnosed with schizophrenia or schizoaffective disorder.You have had a significant problem with drugs or alcohol in the past month.I am 18 years old or older.You have severe disorganized thinking.You have a moderate-to-severe lack of awareness about your illness. This is measured by a specific questionnaire and rating scale.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment
- Group 2: Open Label
- Group 3: Sham Treatment
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any open recruitment opportunities for this research?
"The information posted to clinicaltrials.gov reveals that this trial, which was first published on July 20th 2023 and most recently updated the same day, is not currently enrolling any new participants. However, there are still 390 different trials actively recruiting volunteers at this time."
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