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Completed

NCT Number: NCT02346708

Cognitive Dysfunction in Parkinson's Disease

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real TMS

Device

real treatment

Other names: Transcranial Magnetic Stimulation

Sham TMS

Device

placebo treatment

Primary outcomes

  1. 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

  1. Post-TMS Change From Baseline in Cognitive Scores

    Time frame: 2 weeks

    Our behavioral outcome will be a change in the scores of the following tests:

    Mattis Dementia Rating Scale: Higher raw scores = better cognitive status, ranging from 0 to 144. Normative data in healthy subjects range from 137 to 144.

    Trail Making Test Trails B: average score is 75 seconds; deficient score is > 273 seconds.

    Delis-Kaplan Executive Function System (DKEFS) - Verbal Fluency Test. Higher score = higher ability in language processing. Scales scores vary from 0 min to N/A max (no concrete maximum).

    DKEFS - Stroop Interference Test measures inhibitory control and cognitive flexibility. Performance is measured by completion time. No min or max value for this test. Test should be discontinued after 90 sec.

    For those, higher scores = higher abilities: California Verbal Learning Test (declarative memory, scale 0 to 80), Boston Naming Test (language, scale 0 to 60), Brief Test of Attention and Judgment of Line Orientation (scale 0 to 30)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Jan 27, 2015
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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