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Neuromodulation for Schizophrenia

Primary Purpose

Schizophrenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Non-invasive brainstem modulation device (stimulation Randomized)
Non-invasive brainstem modulation device (stimulation-Open Label)
Sponsored by
Scion NeuroStim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring neuromodulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Investigational Stimulation Pattern 1-Randomized

Investigational Stimulation Pattern 2-Randomized

Investigational Stimulation Pattern-Open Label

Arm Description

Outcomes

Primary Outcome Measures

Illness Awareness
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

Examine changes in brain network activity
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.

Full Information

First Posted
October 11, 2022
Last Updated
October 13, 2022
Sponsor
Scion NeuroStim
Collaborators
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT05580211
Brief Title
Neuromodulation for Schizophrenia
Official Title
The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2022 (Anticipated)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scion NeuroStim
Collaborators
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Stimulation Pattern 1-Randomized
Arm Type
Other
Arm Title
Investigational Stimulation Pattern 2-Randomized
Arm Type
Other
Arm Title
Investigational Stimulation Pattern-Open Label
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Non-invasive brainstem modulation device (stimulation Randomized)
Intervention Description
Study participants will receive ~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.
Intervention Type
Device
Intervention Name(s)
Non-invasive brainstem modulation device (stimulation-Open Label)
Intervention Description
Study participants will receive ~19-minute treatments twice daily in the clinic setting over 8 weeks using a non-invasive brainstem modulation device.
Primary Outcome Measure Information:
Title
Illness Awareness
Description
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.
Time Frame
4 weeks from baseline to end of treatment
Secondary Outcome Measure Information:
Title
Examine changes in brain network activity
Description
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.
Time Frame
4 weeks from baseline to end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Unwilling or unable to consent to the study Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease Had eye surgery within the previous three (3) months Ear surgery within 6 months prior to entering the study Active ear infection or perforated tympanic membrane Diagnosis of vestibular dysfunction Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures Acute suicidal and/or homicidal ideation Formal thought disorder rating ≥4 on PANSS item P2 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 Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phillip Gerretson, MD
Phone
416-535-8501
Ext
39426
Email
Philip.Gerretsen@camh.ca
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Gerretson, MD
Phone
416-535-8501
Ext
39426

12. IPD Sharing Statement

Learn more about this trial

Neuromodulation for Schizophrenia

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