Cerebellar Stimulation and Cognitive Control
Cerebellar Transcranial Magnetic Stimulation and Cognitive Control
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Nov 2017
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 19, 2026
March 1, 2026
11 years
June 30, 2017
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (15)
Change in brain rhythms
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in cognitive function
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Changes in functional MRI
During the 1 week of treatment comparing pre- and post-stimulation scans.
Change in NIH Toolbox emotion battery
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in motor function
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
- +10 more secondary outcomes
Study Arms (4)
patient active rTMS
EXPERIMENTALSubjects will receive 5 days of 2x daily rTMS targeted over the cerebellum.
patient sham rTMS
SHAM COMPARATORSubjects will receive 5 days of 2x daily sham stimulation of the cerebellum.
Control active rTMS
ACTIVE COMPARATORControl sham rTMS
SHAM COMPARATORInterventions
Subjects with neuropsychiatric diagnoses and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.
Subjects with neuropsychiatric diagnoses and matched-controls will be receive theta frequency stimulation of the cerebellum. We will target the cerebellar vermis.
Eligibility Criteria
You may qualify if:
- A clinical diagnosis consistent with enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa
Iowa City, Iowa, 52245, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krystal L Parker, Ph.D
Univeristy of Iowa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 30, 2017
First Posted
July 13, 2017
Study Start
November 30, 2017
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share