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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03217110
Other study ID # 201610712
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2017
Est. completion date August 1, 2024

Study information

Verified date May 2023
Source University of Iowa
Contact Krystal L Parker, Ph.D
Phone 319-353-4554
Email CT201610712@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States University of Iowa Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Krystal Parker, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in brain rhythms 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.
Secondary Change in cognitive function 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.
Secondary Changes in functional MRI Changes in resting-state functional connectivity. During the 1 week of treatment comparing pre- and post-stimulation scans.
Secondary Change in NIH Toolbox emotion battery 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.
Secondary Change in motor function 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.
Secondary Schizophrenia group: Change in Calgary depression scale. 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.
Secondary Bipolar group: Change in Young Mania Rating Scale. 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.
Secondary Bipolar group: Change in Columbia Suicide Severity Rating Scale. 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.
Secondary Change in PHQ9 score. 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.
Secondary Change in CGI. 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.
Secondary Change in cognitive function. 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.
Secondary Changes in structural MRI. Changes in volumetrics in the active treatment group as compared to sham. During the 1 week of treatment comparing pre- and post-stimulation scans.
Secondary Changes in MRI-based timing task. 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.
Secondary Changes in DTI. 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.
Secondary Changes in T1 rho MRI signal. 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.
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