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NCT Number: NCT03217110

Cerebellar 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

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 repetitive transcranial magnetic stimulation (rTMS)

Device

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

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).

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Changes in functional MRI

    Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.

    Changes in resting-state functional connectivity.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Pace, M.S.

CONTACT

[email protected]

319-384-9302

Krystal L Parker, Ph.D

CONTACT

[email protected]

319-353-4554

Sponsors and collaborators

Lead sponsor

Krystal Parker, PhD

Other

Registry information

Official study title

Cerebellar Transcranial Magnetic Stimulation and Cognitive Control

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Jul 13, 2017
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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