Cerebellar Stimulation and Cognitive Control
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (rTMS).
- Who it may be relevant to
- Registry conditions: Schizophrenia, Autism Spectrum Disorder, Bipolar Disorder, Depression. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cerebellar Transcranial Magnetic Stimulation and Cognitive Control
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- 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.]
Secondary outcome measures (12)
- 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 in cognitive function [Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.]
- Changes in functional MRI [Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.]
- 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.]
- Change in motor function [Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.]
- 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.]
- 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.]
- 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.]
- Change in PHQ9 score. [Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.]
- Change in CGI. [Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.]
- Change in cognitive function. [Time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.]
- Changes in structural MRI. [Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Iowa — Iowa City
Identifiers
NCT: NCT03217110 · 201610712