Cerebellar Stimulation and Cognitive Control

Krystal Parker, PhD

Status: Enrolling

Conditions: Autism Spectrum Disorder; Schizophrenia; Bipolar Disorder; Parkinson Disease; Depression

Treatments: Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03217110

201610712

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

patient active rTMS

Experimental group

Description:

Subjects will receive 5 days of 2x daily rTMS targeted over the cerebellum.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

patient sham rTMS

Sham Comparator group

Description:

Subjects will receive 5 days of 2x daily sham stimulation of the cerebellum.

Treatment:

Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Control active rTMS

Active Comparator group

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Control sham rTMS

Sham Comparator group

Treatment:

Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)