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Cognitive Dysfunction in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02346708
Recruitment Status : Active, not recruiting
First Posted : January 27, 2015
Results First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE January 9, 2015
First Posted Date  ICMJE January 27, 2015
Results First Submitted Date  ICMJE April 6, 2020
Results First Posted Date  ICMJE December 9, 2020
Last Update Posted Date December 9, 2020
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2020)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
change in cognitive scores [ Time Frame: 2 weeks ]
Our behavioral outcome will be a change in the scores of the following tests: 1) Mattis Dementia Rating Scale 2) Executive function (Trails B, Verbal Fluency, Stroop); 3) Memory (Hopkins Verbal Learning Test); 4) Language (Boston Naming Test); 5) Attention (Brief Test of Attention); and 6) Visuospatial (Judgment of Line Orientation).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Dysfunction in Parkinson's Disease
Official Title  ICMJE Cortical Physiology as a Therapeutic Target in Parkinson's Disease Related Dementia and Cognitive Dysfunction
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Device: Real TMS
    real treatment
    Other Name: Transcranial Magnetic Stimulation
  • Device: Sham TMS
    placebo treatment
Study Arms  ICMJE
  • Experimental: Real TMS
    TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magstim Stimulator. Repetitive pulses will be delivered to the right and left pre-frontal cortex (Brodmann area 46) using a frameless stereotactic navigation system and the subject's magnetic resonance imaging (MRI) in Brainsight software. Stimuli will be delivered at 20 Hz at 90% resting motor threshold (rMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. This dose and duration of repetitive TMS (rTMS) is based on physiological studies of healthy adults and treatment studies of cognition in PD and Alzheimer's disease.52, 123 Side of first stimulation (left vs right hemisphere) will be counterbalanced across subjects.
    Intervention: Device: Real TMS
  • Sham Comparator: Sham TMS
    Sham stimulation will be delivered using a sham coil fitted with electrodes to mimic both the auditory and somatic sensation of real TMS.
    Intervention: Device: Sham TMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 8, 2020)
49
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2015)
150
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02346708
Other Study ID Numbers  ICMJE 13-2724
1K02NS080885-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available to the scientific community upon request.
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Benzi M Kluger, MD, MS University of Colorado School of Medicine
PRS Account University of Colorado, Denver
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP