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| ID | Type | Description | Link |
|---|---|---|---|
| 12246865 | Other Grant/Funding Number | Veterans Affairs - Rehabilitation R&D | |
| 38101 | Other Identifier | Stanford IRB |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| University of South Carolina | OTHER |
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The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) is effective in remediating cognitive deficits while also improving functionality in Veterans with schizophrenia.
High-frequency, repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), the dysfunctional brain region most implicated in cognitive deficits in schizophrenia, has recently been shown to improve cognition in non-Veteran samples with schizophrenia. The investigators' goal is to confirm the efficacy of this treatment modality to remediate cognitive deficits and improve functionality in Veterans with schizophrenia, as well as to gain a better understanding of the neural mechanisms responsible for cognitive deficits and their remediation. The investigators propose conducting a small-scale study to generate pilot data supporting the feasibility of conducting rTMS with Veterans and the effectiveness of rTMS in this population. In addition, the investigators will conduct neurophysiologic experiments to test whether certain neural maker of abnormal brain function improves with rTMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Active Comparator | Subjects will receive actual rTMS treatment. |
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| Sham rTMS | Sham Comparator | Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation | Device | rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Working Memory Function | Changes in scores for working memory performance accuracy will serve as dependent measure for testing the hypothesis that rTMS improves working memory. Working memory performance was assessed using a non-standardized task developed in house, which is basically a Sterberg style delayed response task in which memoranda are displayed and are to be remembered across a short delay period. The hypothesis will be supported if the investigators find greater working memory difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Scores will be reported as a change in percent accuracy during this working memory task, where higher percent accuracy is better and scores range from -100% to 100%. | before treatment and after 6-week treatment |
| Change in Neurophysiologic Function | Gamma oscillation is viewed as a measure of neurophysiologic function. The investigators will be conducting task-evoked electroencephalography (EEG) to measure gamma oscillation before and after rTMS. It is predicted that the intervention will improve gamma oscillations. | before treatment and after 6-week treatment |
| Change in Level of Everyday Functioning | Changes in Global Functioning Scale scores (GF) will serve as dependent measure for testing the hypothesis that rTMS improves functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Scale's values range from a minimum score of 1 to a maximum score of 10, with a higher score means better functioning. | before treatment and after 6-week treatment |
| Change in General Cognitive Ability | Changes in Brief Assessment of Cognition (BACS) score will serve as a dependent measure for testing the hypothesis that rTMS improves cognitive functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Data will be reported as change in Z-score on the scale, where a higher value means a better outcome, with scores ranging from -3 to 3. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating female
History of prior adverse reaction to TMS
On medications known to significantly lower seizure threshold, e.g.:
History of seizures or conditions known to substantially increase risk for seizures
Implants or medical devices incompatible with TMS
Acute or unstable chronic illness that would affect participation or compliance with study procedures, e.g.:
Substance abuse/dependence (not including caffeine or nicotine) within one-month period prior to study entry or during study participation
Unstable psychiatric symptoms that precludes consistent participation in the study, e.g.:
History of loss of consciousness greater than 15 minutes due to head injury.
Participation in another concurrent clinical trial
Patients with prior exposure to rTMS
Have a mass lesion, cerebral infarct or other active central nervous system disease, or history of traumatic brain injury
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| Name | Affiliation | Role |
|---|---|---|
| Jong H. Yoon, MD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | United States |
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Of the approached potential participants, many were unable to participate due to difficulties with the amount of time required to participate in the study, or a change in interest.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between. |
| FG001 | Sham | Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between. |
| 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 | Change in Working Memory Function | Changes in scores for working memory performance accuracy will serve as dependent measure for testing the hypothesis that rTMS improves working memory. Working memory performance was assessed using a non-standardized task developed in house, which is basically a Sterberg style delayed response task in which memoranda are displayed and are to be remembered across a short delay period. The hypothesis will be supported if the investigators find greater working memory difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Scores will be reported as a change in percent accuracy during this working memory task, where higher percent accuracy is better and scores range from -100% to 100%. | Posted | Mean | Standard Deviation | % change in Working Memory Task Accuracy | before treatment and after 6-week treatment |
|
Adverse event data was collected for one month after the initiation of the intervention
No difference in definitions used.
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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 | Subjects will receive actual rTMS treatment. Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Hospitalization | Psychiatric disorders | Systematic Assessment | Hospitalization likely not causally related to study participation since it was triggered by drug use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jong Yoon | Palo Alto VA | 510-220-7086 | jhyoon1@stanford.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 | Jun 18, 2018 | May 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| 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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|
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| Sham | Device | Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject. |
|
| before treatment and after 6-week treatment |
| BG001 | Sham | Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Brief Assessment of Cognition in Schizophrenia (BACS) Composite T-score Score at Baseline | The Brief Assessment of Cognition in Schizophrenia (BACS) represents cognitive ability of people with schizophrenia, where scores from six sub-scales of cognition were normalized to a composite T-score in which the normalized T-score has a mean of 50 and S.D. of 10 of the reference groups, where a higher score significantly above the mean indicates greater cognitive ability. Alternatively, scoring significantly below the mean would indicate lower cognitive ability as reflected in the data. | Mean | Standard Deviation | T-score |
|
Subjects will receive actual rTMS treatment.
Repetitive transcranial magnetic stimulation: rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.
| OG001 | Sham | Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject. |
|
|
|
| Primary | Change in Neurophysiologic Function | Gamma oscillation is viewed as a measure of neurophysiologic function. The investigators will be conducting task-evoked electroencephalography (EEG) to measure gamma oscillation before and after rTMS. It is predicted that the intervention will improve gamma oscillations. | Posted | Mean | Standard Deviation | wavelet coefficient in dB | before treatment and after 6-week treatment |
|
|
|
| Primary | Change in Level of Everyday Functioning | Changes in Global Functioning Scale scores (GF) will serve as dependent measure for testing the hypothesis that rTMS improves functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Scale's values range from a minimum score of 1 to a maximum score of 10, with a higher score means better functioning. | Posted | Mean | Standard Deviation | score on a scale | before treatment and after 6-week treatment |
|
|
|
|
| Primary | Change in General Cognitive Ability | Changes in Brief Assessment of Cognition (BACS) score will serve as a dependent measure for testing the hypothesis that rTMS improves cognitive functioning. The hypothesis will be supported if the investigators find greater GF-difference in the active compared to the sham-rTMS-treated groups as revealed by t-tests and two-sided tests at an alpha level of 0.05. Data will be reported as change in Z-score on the scale, where a higher value means a better outcome, with scores ranging from -3 to 3. | Posted | Mean | Standard Deviation | Z-score | before treatment and after 6-week treatment |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| 0 |
| 5 |
| EG001 | Sham | Subjects will attend and sit through the session, but no rTMS treatment will be actually delivered to them. Sham: Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject. | 0 | 4 | 0 | 4 | 0 | 4 |
|
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