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Principal Investigator took another position elsewhere
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The major goal is to determine if Transcranial magnetic stimulation (TMS) enhances visual plasticity in schizophrenia. TMS sessions (sham/placebo and real TMS) will be conducted before two MRI scans with two weeks in-between to assess whether TMS stimulation to the visual cortex will enhance visual plasticity in patients with schizophrenia-spectrum disorders. This project may provide a better understanding of the underlying neurobiological mechanisms responsible for learning and memory deficits in schizophrenia.
Learning and memory impairments are commonly observed in schizophrenia spectrum disorders. Alterations in "long-term potentiation" (LTP), a basic mechanism underlying learning and memory, may explain this impairment. This project will assess fMRI visual plasticity, thought to reflect LTP, in participants with and without schizophrenia spectrum disorders. Previous studies have shown that visual plasticity is impaired in schizophrenia. The major goal is to determine if Transcranial magnetic stimulation (TMS) enhances visual plasticity in schizophrenia. Transcranial magnetic stimulation (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS sessions (sham/placebo and real TMS) will be conducted before two MRI scans with two weeks in-between to assess whether TMS stimulation to the visual cortex will enhance visual plasticity in patients with schizophrenia-spectrum disorders. This project may provide a better understanding of the underlying neurobiological mechanisms responsible for learning and memory deficits in schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS | Active Comparator | rTMS |
|
| Sham TMS | Sham Comparator | A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Transcranial Magnetic Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| fMRI Blood Oxygenation Level Dependent (BOLD) Response of Visual Plasticity | fMRI BOLD response in visual cortex, during visual stimulation (0.9 Hz) before and after high frequency visual stimulation (9 Hz). | ~1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Spectroscopy (MRS) Assessment of Glutamate | MRS was used to obtain occipital cortical glutamate levels (active, sham). Levels reflect institutional units, as is standard for the field. | ~1 hour |
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Inclusion Criteria:
Healthy controls will have no DSM-5 diagnosis and no first-degree relatives with a psychotic disorder.
Inclusion criteria for patients includes:
Exclusion Criteria:
Healthy controls with a DSM-5 diagnosis and/or a first-degree relative with a psychotic disorder. Participants with schizophrenia that are not competent to sign an informed consent, have more than 12 months antipsychotic exposure, not on the same psychotropic medications for 4 weeks prior to study, taking clozapine, and not clinically stable (i.e.a change in psychotic symptoms for at least 4 weeks).
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| Name | Affiliation | Role |
|---|---|---|
| Laura M Rowland, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21228 | United States |
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17 adults provided informed consent. 2 screen failures and 1 lost to follow-up before screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | TMS (Active Then Sham) | Participants first received active rTMS 10Hz to the occipital cortex and then 2 weeks later received sham (A sham coil was used to control for the auditory artifacts induced by rTMS) TMS: Transcranial Magnetic Stimulation |
| FG001 | TMS (Sham Then Active) | Participants first received sham (A sham coil was used to control for the auditory artifacts induced by rTMS) and then 2 weeks later received active rTMS 10Hz to the occipital cortex TMS: Transcranial Magnetic Stimulation |
| FG002 | iTBS (Active Then Sham) | Participants first received active iTBS 5 Hz to the occipital cortex and then 2 weeks later received sham (a sham coil was used to control for the auditory artifacts induced by iTBS). Intermittent theta-burst stimulation: iTBS |
| FG003 | iTBA (Sham Then Active) | Participants first received sham (a sham coil was used to control for the auditory artifacts induced by iTBS) and then 2 weeks later received active iTBS 5 Hz to the occipital cortex . Intermittent theta-burst stimulation: iTBS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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No participants were randomized to TMS (Sham then Active) condition
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| ID | Title | Description |
|---|---|---|
| BG000 | TMS (Active Then Sham) | Participants first received active rTMS 10Hz to the occipital cortex and then 2 weeks later received sham (A sham coil was used to control for the auditory artifacts induced by rTMS) |
| BG001 | TMS (Sham Then Active) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | fMRI Blood Oxygenation Level Dependent (BOLD) Response of Visual Plasticity | fMRI BOLD response in visual cortex, during visual stimulation (0.9 Hz) before and after high frequency visual stimulation (9 Hz). | 13 participants completed active and/or sham conditions for either TMS or iTBS | Posted | Mean | Standard Deviation | Beta values | ~1 hour |
|
Adverse events were assessed during active and sham sessions, 3 hours each, for up to 2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active TMS 10 Hz | rTMS 10Hz to the occipital cortex Transcranial Magnetic Stimulation: Transcranial Magnetic Stimulation |
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Early termination leading to small numbers unable to statistically analyze.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Laura Rowland | University of Maryland Baltimore | 410-402-6073 | lrowland@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2017 | Apr 1, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Participants first received sham (A sham coil was used to control for the auditory artifacts induced by rTMS) and then 2 weeks later received active rTMS 10Hz to the occipital cortex |
| BG002 | iTBS (Active Then Sham) | Participants first received active iTBS 5 Hz to the occipital cortex and then 2 weeks later received sham (a sham coil was used to control for the auditory artifacts induced by iTBS). |
| BG003 | iTBS (Sham Then Active) | Participants first received sham (a sham coil was used to control for the auditory artifacts induced by iTBS) and then 2 weeks later received active iTBS 5 Hz to the occipital cortex |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Patient: Active iTBS | iTBS 5 Hz to the occipital cortex Intermittent theta-burst stimulation: iTBS |
| OG003 | Patient: Sham iTBS | A sham coil will be used. This condition controls for the auditory artifacts induced by iTBS Intermittent theta-burst stimulation: iTBS |
| OG004 | Control: Active TMS 10 Hz | rTMS 10Hz to the occipital cortex Transcranial Magnetic Stimulation: Transcranial Magnetic Stimulation |
| OG005 | Control: Sham TMS | A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS. TMS: Transcranial Magnetic Stimulation |
| OG006 | Control: Active iTBS | iTBS 5 Hz to the occipital cortex Intermittent theta-burst stimulation: iTBS |
| OG007 | Control: Sham iTBS | A sham coil will be used. This condition controls for the auditory artifacts induced by iTBS Intermittent theta-burst stimulation: iTBS |
|
|
| Secondary | Magnetic Resonance Spectroscopy (MRS) Assessment of Glutamate | MRS was used to obtain occipital cortical glutamate levels (active, sham). Levels reflect institutional units, as is standard for the field. | 2 participants had missing data; 11 participants completed active and sham conditions for either TMS or iTBS | Posted | Mean | Standard Deviation | spectroscopy institutional units | ~1 hour |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Sham TMS | A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS. Transcranial Magnetic Stimulation: Transcranial Magnetic Stimulation | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Active iTBS | iTBS 5 Hz to the occipital cortex Intermittent theta-burst stimulation: iTBS | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Sham iTBS | A sham coil will be used. This condition controls for the auditory artifacts induced by iTBS Intermittent theta-burst stimulation: iTBS | 0 | 10 | 0 | 10 | 0 | 10 |
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