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Clinical Trials/NCT03217110
NCT03217110
Recruiting
N/A

Cerebellar Transcranial Magnetic Stimulation and Cognitive Control

Krystal Parker, PhD1 site in 1 country200 target enrollmentNovember 30, 2017

Overview

Phase
N/A
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Conditions
Schizophrenia
Sponsor
Krystal Parker, PhD
Enrollment
200
Locations
1
Primary Endpoint
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).
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 30, 2017
End Date
December 1, 2028
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Krystal Parker, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Krystal Parker, PhD

Assistant Professor

University of Iowa

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

Arms & Interventions

patient active rTMS

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

Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS)

patient sham rTMS

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

Intervention: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Control active rTMS

Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS)

Control sham rTMS

Intervention: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in CGI.(During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.)
  • Changes in functional MRI(During the 1 week of treatment comparing pre- and post-stimulation scans.)
  • Change in PHQ9 score.(During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.)
  • Changes in MRI-based timing task.(During the 1 week of treatment comparing pre- and post-stimulation scans.)
  • Changes in DTI.(During the 1 week of treatment comparing pre- and post-stimulation scans.)
  • Change in cognitive function(During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.)
  • Change in motor function(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.(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.(During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.)
  • Change in cognitive function.(During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.)
  • Change in brain rhythms(During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.)
  • Change in NIH Toolbox emotion battery(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.(During the 1 week of treatment, with follow up 1 week, 3 weeks, and 2 months post-stimulation.)
  • Changes in structural MRI.(During the 1 week of treatment comparing pre- and post-stimulation scans.)
  • Changes in T1 rho MRI signal.(During the 1 week of treatment comparing pre- and post-stimulation scans.)

Study Sites (1)

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