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Clinical Trials/NCT02346708
NCT02346708
Completed
Not Applicable

Cortical Physiology as a Therapeutic Target in Parkinson's Disease Related Dementia and Cognitive Dysfunction

University of Colorado, Denver1 site in 1 country49 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
University of Colorado, Denver
Enrollment
49
Locations
1
Primary Endpoint
Change in Magnetoencephalography (MEG) Connectivity Measures
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study plans to learn more about the brain function related to thinking problems in individuals with Parkinson's disease.

Detailed Description

Dementia is the leading cause of nursing home placement in Parkinson's disease (PD) yet little is known about the cause(s) of cognitive dysfunction in PD and there are no effective treatments. The investigators preliminary data and other published studies suggest that abnormalities in brain activity involving networks important for normal thinking and memory may contribute to cognitive dysfunction in PD and may represent a target for treatment. This proposal will identify abnormalities in cortical activity related to cognitive dysfunction in PD using magnetoencephalography and will perform a randomized control trial of bifrontal repetitive transcranial magnetic stimulation to determine the therapeutic potential of modulating this brain activity.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of probable PD (using United Kingdom Brain Bank criteria)
  • Diagnosis of mild cognitive impairment
  • No unstable medical condition

Exclusion Criteria

  • Features suggestive of other causes of Parkinsonism or other neurological disorders
  • Prior deep brain stimulation (DBS) or ablation surgery
  • Evidence for active depression or Hospital Anxiety and Depression Scale (HADS) score greater than or equal to 11
  • Motor symptoms expected to interfere with scanning (e.g. sever tremor)
  • Contraindications to TMS, MEG, or MRI such as pregnancy, pacemaker, unstable cardiac disease, skull lesion, claustrophobia, history of epilepsy, or on medications known to lower seizure threshold
  • Implanted electronic devices or metal

Outcomes

Primary Outcomes

Change in Magnetoencephalography (MEG) Connectivity Measures

Time Frame: 2 weeks

Our MEG outcome will be a change in small-worldness, global efficiency, nodal efficiency and degree distribution pre-TMS to immediately post-TMS treatment.

Secondary Outcomes

  • Post-TMS Change From Baseline in Cognitive Scores(2 weeks)

Study Sites (1)

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