Neuromodulation for Schizophrenia

• Sponsor: Scion NeuroStim (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05580211
• Collaborator: Centre for Addiction and Mental Health (Other)
• Enrollment: 34
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 39.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: Non-invasive brainstem modulation device (stimulation Randomized); Device: Non-invasive brainstem modulation device (stimulation-Open Label)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: During the Phase I, all participants are randomized to one of two treatment stimulation patterns. In Phase II, all participants will receive the same treatment pattern.
• Primary Purpose: Treatment
• Official Title: The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
• Anticipated Study Start Date: Oct 15, 2022
• Anticipated Primary Completion Date: Oct 30, 2025
• Anticipated Study Completion Date: Jan 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Investigational Stimulation Pattern 1-Randomized	Device: 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.
Other: Investigational Stimulation Pattern 2-Randomized	Device: 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.
Other: Investigational Stimulation Pattern-Open Label	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.

Outcome Measures

Primary Outcome Measures

1. Illness Awareness [4 weeks from baseline to end of treatment]

   functional MRI paradigm. The paradigm consists of a bank of brief questions or statements to which participants respond either "yes/agree" or "no/disagree". The brief statements are derived from four categories: general illness awareness, symptom awareness and attribution, awareness of need for treatment, and illness independent/control.

Secondary Outcome Measures

1. Examine changes in brain network activity [4 weeks from baseline to end of treatment]

   functional MRI blood oxygen level dependent (BOLD) in response to an illness awareness task pre- and post-treatment. This will serve as a biomarker to rigorously test whether repeated treatment engages the posterior parietal area of the brain associated with illness awareness.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Addiction and Mental Health	Toronto	Ontario	Canada

Sponsors and Collaborators

• Scion NeuroStim
• Centre for Addiction and Mental Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scion NeuroStim
• ClinicalTrials.gov Identifier: NCT05580211
• Other Study ID Numbers: SNS-SCZ-001
• First Posted: Oct 14, 2022
• Last Update Posted: Oct 14, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Scion NeuroStim: neuromodulation
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Oct 14, 2022