University of Iowa
Iowa City, Iowa, 52245, United States
Location status: Recruiting
NCT Number: NCT03217110
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52245, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects with neuropsychiatric diagnoses and matched-controls will be receive theta frequency stimulation of the cerebellum. We will target the cerebellar vermis.
Other names: rTMS
Subjects with neuropsychiatric diagnoses and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.
Other names: Sham stimulation
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change between pre- and post-assessments.
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change from baseline EEG activity in participants receiving stimulation during a timing task.
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Improvement in cognitive function following cerebellar stimulation as compared to controls as measure by higher scores on an NIH Toolbox cognitive battery.
Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in resting-state functional connectivity.
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Improvement in emotion T-scores following cerebellar stimulation as compared to controls
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Improvement in motor function as measured by the Abnormal Involuntary Movement Scale for schizophrenia patients.
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Improvement in Calgary depression scale from pre- to post-treatment assessments.
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Improvement in YMRS scale from pre- to post-treatment.
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Improvement in C-SSRS from pre- to post-treatment.
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Improvement in PHQ9 score from pre- to post-treatment.
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Improvement as measured on CGI from pre- to post-treatment.
Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Improvements as measured by a neuropsychological battery pre and post-treatment.
Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in volumetrics in the active treatment group as compared to sham.
Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.
More accurate evaluation of a passage of time in the MRI scanner in the active treatment group as compared to the control group.
Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.
Greater changes in the white matter tracts of the active treatment group as compared to the control group.
Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.
Normalization of T1 rho abnormalities greater in the active treatment group compared to the control group.
Contact information is provided by the study sponsor or research team.
Benjamin Pace, M.S.
CONTACT
Krystal L Parker, Ph.D
CONTACT
Krystal Parker, PhD
Other
Cerebellar Transcranial Magnetic Stimulation and Cognitive Control
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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