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Cerebellar Stimulation and Cognitive Control

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ClinicalTrials.gov Identifier: NCT03217110
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Krystal Parker, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Autism Spectrum Disorder Bipolar Disorder Depression Parkinson Disease Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Cerebellar Transcranial Magnetic Stimulation and Cognitive Control
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 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 Name: rTMS

Sham Comparator: 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 Name: Sham stimulation




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217110


Contacts
Contact: Krystal L Parker, Ph.D 319-353-4554 CT201610712@gmail.com
Contact: Jonah Heskje, B.S. 319-353-4554 CT201610712@gmail.com

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52245
Contact: Krystal L Parker, Ph.D    319-353-3554    krystal-parker@uiowa.edu   
Sponsors and Collaborators
Krystal Parker
Investigators
Principal Investigator: Krystal L Parker, Ph.D Univeristy of Iowa

Responsible Party: Krystal Parker, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03217110     History of Changes
Other Study ID Numbers: 201610712
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Krystal Parker, University of Iowa:
Cerebellum

Additional relevant MeSH terms:
Disease
Schizophrenia
Parkinson Disease
Bipolar Disorder
Autism Spectrum Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Bipolar and Related Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders