Clinical trial NCT03217110: Cerebellar Stimulation and Cognitive Control
Official title: Cerebellar Transcranial Magnetic Stimulation and Cognitive Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Autism Spectrum Disorder
Bipolar Disorder
Depression
Parkinson Disease
Keywords: Cerebellum
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Secondary outcomes:
measure: Change in brain rhythms
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Change in cognitive function
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Changes in functional MRI
timeFrame: During the 1 week of treatment comparing pre- and post-stimulation scans.
measure: Change in NIH Toolbox emotion battery
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Change in motor function
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Schizophrenia group: Change in Calgary depression scale.
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Bipolar group: Change in Young Mania Rating Scale.
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Bipolar group: Change in Columbia Suicide Severity Rating Scale.
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Change in PHQ9 score.
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Change in CGI.
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Change in cognitive function.
timeFrame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
measure: Changes in structural MRI.
timeFrame: During the 1 week of treatment comparing pre- and post-stimulation scans.
measure: Changes in MRI-based timing task.
timeFrame: During the 1 week of treatment comparing pre- and post-stimulation scans.
measure: Changes in DTI.
timeFrame: During the 1 week of treatment comparing pre- and post-stimulation scans.
measure: Changes in T1 rho MRI signal.
timeFrame: During the 1 week of treatment comparing pre- and post-stimulation scans.
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: Univeristy of Iowa
name: Krystal L Parker, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: