Cerebellar Stimulation and Cognitive Control

Depression Clinical Trial

Official title:

Cerebellar Transcranial Magnetic Stimulation and Cognitive Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217110
• Other study ID #: 201610712
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Bipolar Disorder
• Depression
• Parkinson Disease
• Schizophrenia

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.