Cerebellar Stimulation and Cognitive Control

March 16, 2026 updated by: Krystal Parker, PhD

Cerebellar Transcranial Magnetic Stimulation and Cognitive Control

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • A clinical diagnosis consistent with enrollment

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: patient active rTMS
Subjects will receive 5 days of 2x daily rTMS targeted over the cerebellum.
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.
Other Names:
  • rTMS
Sham Comparator: patient sham rTMS
Subjects will receive 5 days of 2x daily sham stimulation of the cerebellum.
Device: 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.
Other Names:
  • Sham stimulation
Active Comparator: Control active rTMS
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.
Other Names:
  • rTMS
Sham Comparator: Control sham rTMS
Device: 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.
Other Names:
  • Sham stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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).
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.
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in brain rhythms
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.
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in cognitive function
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.
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Changes in functional MRI
Time Frame: During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in resting-state functional connectivity.
During the 1 week of treatment comparing pre- and post-stimulation scans.
Change in NIH Toolbox emotion battery
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
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in motor function
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.
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.
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.
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.
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.
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.
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.
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in PHQ9 score.
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.
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in CGI.
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.
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in cognitive function.
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.
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Changes in structural MRI.
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.
During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in MRI-based timing task.
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.
During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in DTI.
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.
During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in T1 rho MRI signal.
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.
During the 1 week of treatment comparing pre- and post-stimulation scans.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Krystal Parker, PhD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Krystal L Parker, Ph.D, Univeristy of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201610712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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