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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

200

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Krystal Parker, PhD

Investigators

  • 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)

November 30, 2017

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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