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The purpose of this study is to examine whether cerebellar stimulation can be used to improve cognitive deficits and mood in patients with schizophrenia, autism, bipolar disorder, Parkinson's disease, and major depression.
Our recent work found that patients with Parkinson's disease and schizophrenia have impaired frontal EEG rhythms in the theta and delta range (1-8 Hz).We have been using transcranial direct current stimulation to recover these rhythms as patients perform elementary cognitive tasks. We found that although we are able to modulate cerebellar and frontal activity with tDCS, this effect is minimal as the depth of the current is not great enough to modulate all cerebellar activity. Here we use transcranial magnetic stimulation (TMS) to modulate neural activity in the frontal cortex and recover cognitive function in patients with autism, schizophrenia, bipolar disorder and Parkinson's disease.
The purpose of the study is to explore cerebellar stimulation as a potential new treatment to restore frontal activity and cognitive function in autism, schizophrenia, bipolar disorder and Parkinson's disease.Subjects will be brought in for 5 to 6 separate visits, with cerebellar or sham TMS stimulation twice per day for 5 days, as well as 3 follow-up visits.During these visits the patient will have cognitive, disease-specific and emotional testing, including EEG testing and MRI imaging. For those participants that received sham stimulation we will again use EEG to record how single pulses of magnetic or electrical stimulation influences other regions of the cerebellum and downstream brain regions. These data will provide insight into how the cerebellum may influence downstream brain regions and play a role in cognitive and motor performance. All data will be analyzed offline to determine if performance on the interval timing task and/or frontal brain rhythms change following transcranial magnetic stimulation as compared to the pre-stimulation blocks of trials. Additionally, we will analyze changes in their cognitive function, symptom ratings, functional and structural MRI, and mood following stimulation. Controls will receive both active and sham treatment for comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient active rTMS | Experimental | Subjects will receive 5 days of 2x daily rTMS targeted over the cerebellum. |
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| patient sham rTMS | Sham Comparator | Subjects will receive 5 days of 2x daily sham stimulation of the cerebellum. |
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| Control active rTMS | Active Comparator |
| |
| Control sham rTMS | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | Subjects with neuropsychiatric diagnoses and matched-controls will be receive theta frequency stimulation of the cerebellum. We will target the cerebellar vermis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease-specific symptom rating scale, one scale identified for each group (MADRS for bipolar group; PANSS for schizophrenia group; UPDRS in Parkinson's patient group). | Change between pre- and post-assessments. | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain rhythms | Change from baseline EEG activity in participants receiving stimulation during a timing task. | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Change in cognitive function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krystal L Parker, Ph.D | Contact | 319-353-4554 | CT201610712@gmail.com | |
| Benjamin Pace, M.S. | Contact | 319-384-9302 | benjamin-pace@uiowa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Krystal L Parker, Ph.D | Univeristy of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Recruiting | Iowa City | Iowa | 52245 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D000067877 | Autism Spectrum Disorder |
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
| Sham Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | Subjects with neuropsychiatric diagnoses and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis. |
|
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Improvement in cognitive function following cerebellar stimulation as compared to controls as measure by higher scores on an NIH Toolbox cognitive battery.
| During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Changes in functional MRI | Changes in resting-state functional connectivity. | During the 1 week of treatment comparing pre- and post-stimulation scans. |
| Change in NIH Toolbox emotion battery | Improvement in emotion T-scores following cerebellar stimulation as compared to controls | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Change in motor function | Improvement in motor function as measured by the Abnormal Involuntary Movement Scale for schizophrenia patients. | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Schizophrenia group: Change in Calgary depression scale. | Improvement in Calgary depression scale from pre- to post-treatment assessments. | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Bipolar group: Change in Young Mania Rating Scale. | Improvement in YMRS scale from pre- to post-treatment. | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Bipolar group: Change in Columbia Suicide Severity Rating Scale. | Improvement in C-SSRS from pre- to post-treatment. | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Change in PHQ9 score. | Improvement in PHQ9 score from pre- to post-treatment. | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Change in CGI. | Improvement as measured on CGI from pre- to post-treatment. | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Change in cognitive function. | Improvements as measured by a neuropsychological battery pre and post-treatment. | During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation. |
| Changes in structural MRI. | Changes in volumetrics in the active treatment group as compared to sham. | During the 1 week of treatment comparing pre- and post-stimulation scans. |
| Changes in MRI-based timing task. | More accurate evaluation of a passage of time in the MRI scanner in the active treatment group as compared to the control group. | During the 1 week of treatment comparing pre- and post-stimulation scans. |
| Changes in DTI. | Greater changes in the white matter tracts of the active treatment group as compared to the control group. | During the 1 week of treatment comparing pre- and post-stimulation scans. |
| Changes in T1 rho MRI signal. | Normalization of T1 rho abnormalities greater in the active treatment group compared to the control group. | During the 1 week of treatment comparing pre- and post-stimulation scans. |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |