Health TrialsbyHealthPanel

Cerebellar Stimulation and Cognitive Control

ConditionsSchizophreniaAutism Spectrum DisorderBipolar DisorderDepressionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorKrystal Parker, PhD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

A clinical diagnosis consistent with enrollment

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

    Device

    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)

    Device

    Subjects with neuropsychiatric diagnoses and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: patient active rTMSExperimental treatment 1 intervention
Group B: patient sham rTMSSham comparator 1 intervention
Group C: Control active rTMSActive comparator 1 intervention
Group D: Control sham rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.

Secondary outcomes

1

Change in brain rhythms

Change from baseline EEG activity in participants receiving stimulation during a timing task.

Time frame
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
2

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.

Time frame
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
3

Changes in functional MRI

Changes in resting-state functional connectivity.

Time frame
During the 1 week of treatment comparing pre- and post-stimulation scans.
4

Change in NIH Toolbox emotion battery

Improvement in emotion T-scores following cerebellar stimulation as compared to controls

Time frame
During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Krystal Parker, PhD

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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