Cognitive Dysfunction in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346708
• Other study ID #: 13-2724
• Secondary ID: 1K02NS080885-01A
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2020

Study information

• Verified date: January 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Real TMS
real treatment
• Sham TMS
placebo treatment

Locations

Country	Name	City	State
United States	University of Colorado School of Medicine	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Magnetoencephalography (MEG) Connectivity Measures	Our MEG outcome will be a change in small-worldness, global efficiency, nodal efficiency and degree distribution pre-TMS to immediately post-TMS treatment.	2 weeks
Secondary	Post-TMS Change From Baseline in Cognitive Scores	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)	2 weeks