SchizophreniaNCT03217110
Cerebellar Stimulation and Cognitive Control
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Schizophrenia and Autism Spectrum Disorder, run by Krystal Parker, PhD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Autism Spectrum Disorder, Bipolar Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A clinical diagnosis consistent with enrollment
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52245
Krystal L Parker, Ph.D, 319-353-3554, krystal-parker@uiowa.edu
About this study
Official title: Cerebellar Transcranial Magnetic Stimulation and Cognitive Control
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.
Read the 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.
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Cerebellum
- Medical subject headings
- Schizophrenia, Autism Spectrum Disorder, Bipolar Disorder, Depression, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called 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)Device
Also called Sham stimulation
Subjects with neuropsychiatric diagnoses and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.
| Study group | Role | What they receive |
|---|---|---|
| patient active rTMS | Experimental | Subjects will receive 5 days of 2x daily rTMS targeted over the cerebellum. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| patient sham rTMS | Sham comparator | Subjects will receive 5 days of 2x daily sham stimulation of the cerebellum. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Control active rTMS | Active comparator | Not described Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Control sham rTMS | Sham comparator | Not described Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Secondary outcomes (15)
Change in brain rhythms
Change from baseline EEG activity in participants receiving stimulation during a timing task.
Measured: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
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.
Measured: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Changes in functional MRI
Changes in resting-state functional connectivity.
Measured: During the 1 week of treatment comparing pre- and post-stimulation scans.
Change in NIH Toolbox emotion battery
Improvement in emotion T-scores following cerebellar stimulation as compared to controls
Measured: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in motor function
Improvement in motor function as measured by the Abnormal Involuntary Movement Scale for schizophrenia patients.
Measured: 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.
Improvement in Calgary depression scale from pre- to post-treatment assessments.
Measured: 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.
Improvement in YMRS scale from pre- to post-treatment.
Measured: 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.
Improvement in C-SSRS from pre- to post-treatment.
Measured: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in PHQ9 score.
Improvement in PHQ9 score from pre- to post-treatment.
Measured: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in CGI.
Improvement as measured on CGI from pre- to post-treatment.
Measured: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Change in cognitive function.
Improvements as measured by a neuropsychological battery pre and post-treatment.
Measured: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.
Changes in structural MRI.
Changes in volumetrics in the active treatment group as compared to sham.
Measured: During the 1 week of treatment comparing pre- and post-stimulation scans.
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.
Measured: During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in DTI.
Greater changes in the white matter tracts of the active treatment group as compared to the control group.
Measured: During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in T1 rho MRI signal.
Normalization of T1 rho abnormalities greater in the active treatment group compared to the control group.
Measured: During the 1 week of treatment comparing pre- and post-stimulation scans.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start30 Nov 2017
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krystal Parker, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Krystal Parker, PhD, University of Iowa
- Investigators
- Krystal L Parker, Ph.D, Principal investigator, Univeristy of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217110
- Sponsor's protocol ID
- 201610712
- Status last verified
- Mar 2026
- First submitted
- 30 Jun 2017
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar Transcranial Magnetic Stimulation and Cognitive Control
- ClinicalTrials.gov ID
- NCT03217110
- Acronym / sponsor ID
- 201610712
- Keywords
- Cerebellum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Krystal Parker, PhDUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patient active rTMS | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Subjects will receive 5 days of 2x daily rTMS targeted over the cerebellum. |
| patient sham rTMS | Sham comparator | Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)Subjects will receive 5 days of 2x daily sham stimulation of the cerebellum. |
| Control active rTMS | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Control sham rTMS | Sham comparator | Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A clinical diagnosis consistent with enrollment
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Also: rTMSSubjects with neuropsychiatric diagnoses and matched-controls will be receive theta frequency stimulation of the cerebellum. We will target the cerebellar vermis. | Device | Control active rTMS, patient active rTMS |
| Sham Repetitive Transcranial Magnetic Stimulation (rTMS)Also: Sham stimulationSubjects with neuropsychiatric diagnoses and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis. | Device | Control sham rTMS, patient sham rTMS |
Primary outcome
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.
Change between pre- and post-assessments.
15 secondary outcomes
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.
Changes in MRI-based timing task.
Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in DTI.
Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.
Changes in T1 rho MRI signal.
Time frame: During the 1 week of treatment comparing pre- and post-stimulation scans.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krystal L Parker, Ph.D principal investigator
Univeristy of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Schizophrenia and Autism Spectrum Disorder, run by Krystal Parker, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krystal L Parker, Ph.D (319-353-4554, CT201610712@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.