Cognitive Dysfunction in Parkinson's Disease
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|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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Real TMS Device: Sham TMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Cortical Physiology as a Therapeutic Target in Parkinson's Disease Related Dementia and Cognitive Dysfunction|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
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.
Device: Real TMS
Other Name: Transcranial Magnetic Stimulation
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.
Device: Sham TMS
- 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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346708
|United States, Colorado|
|University of Colorado School of Medicine|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Benzi M Kluger, MD, MS||University of Colorado School of Medicine|