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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
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The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).
Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.
Psychotic disorders including schizophrenia, bipolar disorder, and related illnesses are severe, debilitating, and often fatal. Cognitive impairments in psychosis are among the leading predictors of disability and poor quality of life; despite this, there are no first-line interventions to target these symptoms.
This trial will test the hypothesis that cognitive performance in these disorders is modifiable and specifically that it can be modified non-invasively. Transcranial magnetic stimulation (TMS) is a neuromodulation technique that utilizes magnets to alter brain activity non-invasively. TMS has received FDA approval as a therapeutic intervention for multiple psychiatric disorders. In this study, we will use different forms of TMS to modulate a specific brain circuit and we will measure the outcomes of this circuit manipulation. These outcomes include performance on cognitive tests and also changes to the circuit itself that we can measure using magnetic resonance imaging (MRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent theta burst stimulation (iTBS) | Active Comparator | Participants complete MRI scanning and cognitive testing followed by rTMS (iTBS pattern) followed by repeat cognitive testing and MRI scanning |
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| continuous theta burst stimulation (cTBS) | Active Comparator | Participants complete MRI scanning and cognitive testing followed by rTMS (cTBS pattern) followed by repeat cognitive testing and MRI scanning |
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| sham rTMS | Sham Comparator | Participants complete MRI scanning and cognitive testing followed by sham rTMS followed by repeat cognitive testing and MRI scanning |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittant theta burst stimulation (iTBS) | Device | iTBS consists of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses. |
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| Measure | Description | Time Frame |
|---|---|---|
| BACS Symbol Coding test | The BACS Symbol coding test is a test of information processing speed | eight minutes before TMS and one minute after TMS on each of the three TMS visit days |
| BACS Digit Sequence test | The BACS digit sequence test is a test of working memory performance | five minutes before TMS and four minutes after TMS on each of the three TMS visit days |
| functional Magnetic Resonance Imaging | resting-state (task free) functional connectivity | fifteen minutes before TMS and nine minutes after TMS on each of the three TMS visit days |
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Inclusion Criteria:
Exclusion Criteria:
Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month
Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Recruiting | Belmont | Massachusetts | 02478 | United States |
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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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The study design is a crossover design i.e. all participants will receive all three rTMS interventions (iTBS, cTBS, sham rTMS). The participant will be blinded to which intervention is happening on a given study visit. The order of these visits will be determined randomly for each participant.
| continuous theta burst stimulation (cTBS) | Device | cTBS consists of 3 pulses at 50 Hz repeated at 5 Hz (every 200ms) continuously for a total of 600 pulses |
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| sham rTMS | Device | sham rTMS does not deliver a significant change in magnetic field strength |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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