[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03217110":3,"trial-entities:NCT03217110":160,"trial-summary:NCT03217110":163},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":51,"secondary_outcomes":56,"sex":103,"minimum_age":104,"maximum_age":105,"healthy_volunteers":106,"eligibility_criteria":107,"std_ages":127,"locations":130,"central_contacts":146,"overall_officials":154,"references":158,"see_also_links":159},"NCT03217110","201610712","Cerebellar Stimulation and Cognitive Control","Cerebellar Transcranial Magnetic Stimulation and Cognitive Control","RECRUITING","2028-12-01","2026-03","2026-03-19","2017-11-30","Krystal Parker, PhD","OTHER",false,"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.\n\nThe 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\u002For 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.",[19,20,21,22,23],"Schizophrenia","Autism Spectrum Disorder","Bipolar Disorder","Depression","Parkinson Disease",[25],"Cerebellum","INTERVENTIONAL","BASIC_SCIENCE",[29],"NA",{"count":31,"type":32},200,"ESTIMATED",[34,43],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":41},"DEVICE","Repetitive Transcranial Magnetic Stimulation (rTMS)","Subjects with neuropsychiatric diagnoses and matched-controls will be receive theta frequency stimulation of the cerebellum. We will target the cerebellar vermis.",[39,40],"Control active rTMS","patient active rTMS",[42],"rTMS",{"type":35,"name":44,"description":45,"armGroupLabels":46,"otherNames":49},"Sham Repetitive Transcranial Magnetic Stimulation (rTMS)","Subjects with neuropsychiatric diagnoses and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.",[47,48],"Control sham rTMS","patient sham rTMS",[50],"Sham stimulation",[52],{"measure":53,"description":54,"timeFrame":55},"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.",[57,60,63,67,70,73,76,79,82,85,88,91,94,97,100],{"measure":58,"description":59,"timeFrame":55},"Change in brain rhythms","Change from baseline EEG activity in participants receiving stimulation during a timing task.",{"measure":61,"description":62,"timeFrame":55},"Change in cognitive function","Improvement in cognitive function following cerebellar stimulation as compared to controls as measure by higher scores on an NIH Toolbox cognitive battery.",{"measure":64,"description":65,"timeFrame":66},"Changes in functional MRI","Changes in resting-state functional connectivity.","During the 1 week of treatment comparing pre- and post-stimulation scans.",{"measure":68,"description":69,"timeFrame":55},"Change in NIH Toolbox emotion battery","Improvement in emotion T-scores following cerebellar stimulation as compared to controls",{"measure":71,"description":72,"timeFrame":55},"Change in motor function","Improvement in motor function as measured by the Abnormal Involuntary Movement Scale for schizophrenia patients.",{"measure":74,"description":75,"timeFrame":55},"Schizophrenia group: Change in Calgary depression scale.","Improvement in Calgary depression scale from pre- to post-treatment assessments.",{"measure":77,"description":78,"timeFrame":55},"Bipolar group: Change in Young Mania Rating Scale.","Improvement in YMRS scale from pre- to post-treatment.",{"measure":80,"description":81,"timeFrame":55},"Bipolar group: Change in Columbia Suicide Severity Rating Scale.","Improvement in C-SSRS from pre- to post-treatment.",{"measure":83,"description":84,"timeFrame":55},"Change in PHQ9 score.","Improvement in PHQ9 score from pre- to post-treatment.",{"measure":86,"description":87,"timeFrame":55},"Change in CGI.","Improvement as measured on CGI from pre- to post-treatment.",{"measure":89,"description":90,"timeFrame":55},"Change in cognitive function.","Improvements as measured by a neuropsychological battery pre and post-treatment.",{"measure":92,"description":93,"timeFrame":66},"Changes in structural MRI.","Changes in volumetrics in the active treatment group as compared to sham.",{"measure":95,"description":96,"timeFrame":66},"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.",{"measure":98,"description":99,"timeFrame":66},"Changes in DTI.","Greater changes in the white matter tracts of the active treatment group as compared to the control group.",{"measure":101,"description":102,"timeFrame":66},"Changes in T1 rho MRI signal.","Normalization of T1 rho abnormalities greater in the active treatment group compared to the control group.","ALL","18 Years","90 Years",true,{"inclusion":108,"exclusion":110,"raw_text":126},[109],"A clinical diagnosis consistent with enrollment",[111,112,113,114,115,116,117,118,119,120,121,122,123,124,125],"History of recurrent seizures or epilepsy","Any other neurological or psychiatric diagnosis outside the diagnosis for which the participant is enrolled.","Active substance use disorder in the past 6 months other than tobacco use disorder.","Inability to consent for study.","Pacemaker","Coronary Stent","Defibrillator","Neurostimulation","Claustrophobia","Uncontrolled high blood pressure","Atrial fibrillation","Significant heart disease","Hemodynamic instability","Kidney disease","Pregnant, trying to become pregnant, or breast feeding","Inclusion Criteria:\n\n* A clinical diagnosis consistent with enrollment\n\nExclusion Criteria:\n\n* History of recurrent seizures or epilepsy\n* Any other neurological or psychiatric diagnosis outside the diagnosis for which the participant is enrolled.\n* Active substance use disorder in the past 6 months other than tobacco use disorder.\n* Inability to consent for study.\n* Pacemaker\n* Coronary Stent\n* Defibrillator\n* Neurostimulation\n* Claustrophobia\n* Uncontrolled high blood pressure\n* Atrial fibrillation\n* Significant heart disease\n* Hemodynamic instability\n* Kidney disease\n* Pregnant, trying to become pregnant, or breast feeding",[128,129],"ADULT","OLDER_ADULT",[131],{"facility":132,"status":8,"city":133,"state":134,"zip":135,"country":136,"contacts":137,"geoPoint":143},"University of Iowa","Iowa City","Iowa","52245","United States",[138],{"name":139,"role":140,"phone":141,"email":142},"Krystal L Parker, Ph.D","CONTACT","319-353-3554","krystal-parker@uiowa.edu",{"lat":144,"lon":145},41.66113,-91.53017,[147,150],{"name":139,"role":140,"phone":148,"email":149},"319-353-4554","CT201610712@gmail.com",{"name":151,"role":140,"phone":152,"email":153},"Benjamin Pace, M.S.","319-384-9302","benjamin-pace@uiowa.edu",[155],{"name":139,"affiliation":156,"role":157},"Univeristy of Iowa","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":161,"biomarkers":162},[20,21,22,23,19],[],{"nct_id":4,"found":106,"summary":164,"prompt_version":174},{"design":165,"status":166,"heading":167,"summary":168,"follow_up":169,"word_count":170,"commitments":171,"compensation":172,"drugs_mentioned":173},"This is an interventional study that plans to enroll 200 participants. Some participants will receive active rTMS, while others will receive sham (inactive) rTMS.","completed","Cerebellar Stimulation and Cognitive Control Study","This study is exploring if a treatment called Repetitive Transcranial Magnetic Stimulation (rTMS) can help improve thinking and mood in people with certain conditions. rTMS uses magnetic pulses to stimulate a part of the brain called the cerebellum. Researchers want to see if stimulating the cerebellum can help restore normal brain activity in people with schizophrenia, autism spectrum disorder, bipolar disorder, depression, and Parkinson's disease. You might be able to join if you are between 18 and 90 years old and have one of these diagnoses. The study will measure success by looking at changes in symptom rating scales specific to each condition, like the MADRS for bipolar disorder or PANSS for schizophrenia. The current status of this study is unclear, but it plans to enroll 200 participants.","Participants will be followed for 1 week, 3 weeks, and 2 months after the stimulation treatment.",128,"You would have 5 to 6 separate visits for treatment, with rTMS or sham stimulation twice daily for 5 days. There will also be 3 follow-up visits, including cognitive, disease-specific, emotional, EEG, and MRI testing.","Not stated in the trial record.",[36],"v2"]