Clinical trial NCT05495997: Cognitive Training in Parkinson's Disease
Official title: Effects of Cognitive Training on Everyday Cognitive and Brain Function in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-08-10
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine whether cognitive training will improve cognitive and brain functions in people with Parkinson's Disease (PD) during activities of daily living using cognitive evaluations and magnetic resonance imaging (MRI).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic PD
* Age ≥ 40 years
* Expected to be on a stable dopaminergic medication regimen throughout the study period

Exclusion Criteria:

* Non-English speaking
* Pregnancy
* Breastfeeding
* Excessive alcohol consumption (\> 7 drinks per week for women, \> 14 drinks per week for men) or illicit substance use
* History of a neurological disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, movement disorder (other than PD), or seizures
* History of schizophrenia, bipolar disorder, attention deficit disorder, or obsessive-compulsive disorder
* History of head injury with loss of consciousness longer than a few minutes
* Metallic surgical implants or traumatically implanted metallic foreign bodies
* Inability to lie flat for about an hour in the MRI scanner
* Discomfort being in small, enclosed spaces
* Dementia at screening (Montreal Cognitive Assessment score \< 21/30)
* Cognitive problems in activities of daily living suggestive of more than mild cognitive impairment (PD Cognitive Functional Rating Scale \> 4)
* Mild cognitive impairment according to the Movement Disorders Society (MDS) Level II comprehensive assessment criteria (\> 1.5 standard deviations below the norm in two tests in a single cognitive domain or in one test in two separate cognitive domains, with the exception that the executive domain scores can be up to 2 standard deviations below the norm)
* Hoehn \& Yahr stage \> 3 (i.e., able to stand and walk, but not fully independent)
* Focal neurological findings on exam that suggest cerebral pathology other than that associated with parkinsonism
* Motor symptoms that could potentially introduce too much motion artifact in the imaging data (e.g., MDS-Unified PD Rating Scale resting tremor score \> 2 in limbs, head/chin tremor, or more than mild dyskinesia by history or exam)

Primary outcomes:
measure: Change in Quality of life in Neurological Disorders (Neuro-QoL) Version 2 Cognitive Function scores
timeFrame: At baseline, 6 weeks, and 18 weeks.
measure: Change in task-specific whole-brain functional connectivity
timeFrame: At baseline, 6 weeks, and 18 weeks.
Secondary outcomes:
measure: Change in composite executive function test scores
timeFrame: At baseline, 6 weeks, and 18 weeks.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Sule Tinaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: