Cognitive Dysfunction in Parkinson's Disease

University of Colorado, Denver49 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson's Disease

Interventions

Real TMSDEVICE

real treatment

Sham TMSDEVICE

placebo treatment

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado School of Medicine

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 weeks

Secondary Outcomes

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)

Time frame: 2 weeks

Data from ClinicalTrials.gov

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