Clinical trial NCT05498493: Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment
Official title: Assessing the Effectiveness of Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot randomized controlled trial is to investigate the feasibility and efficacy of cognitive rehabilitation for patients with post-COVID-19 cognitive impairment. Additionally, the study will obtain preliminary data, using rsfMRI, regarding the potential underlying connectivity networks, mediating the effect of CR on cognitive improvements.


Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years of age
* Have a confirmed SARS-CoV-2 infection (positive PCR or are serum antibody positive \[against spike protein if unvaccinated or N-capsid peptide if vaccinated\])
* Speak English
* Have objective mild to moderate cognitive impairment, which will be defined as impairment in executive function (a z-score \>1.5 standard deviations below the normative mean) and in at least one other cognitive domain
* Endorse comfort and familiarity with technology.

Exclusion Criteria:

* No method of contact
* Major neurocognitive disorder, as defined by a score \<17 on the Montreal Cognitive Assessment (MoCA)
* History of pre-COVID-19 neurologic disease (e.g., stroke)
* History of severe head injury (as defined by loss of consciousness \>30 minutes)
* Ongoing substance use disorder (Mini International Neuropsychiatric Interview Version 7.0.2 \[MINI\] or Alcohol Use Disorders Test-Consumption \[AUDIT-C\] \>8)
* Unstable medical, neurologic, or psychiatric conditions precluding participation in research activities, and
* Contraindication for MRI (e.g., metallic/electronic implants).
* Not involved in cognitive rehabilitation/training or daily meditative practices during study enrollment

Primary outcomes:
measure: Trail Making Test - Part B
timeFrame: end of study, at 12 months
measure: Wisconsin Card Sorting Task (WCST)-64
timeFrame: end of study, at 12 months
measure: Acceptability Scale
timeFrame: end of study, at 12 months
measure: Enrollment yield
timeFrame: end of study, at 12 months
measure: Dropout number
timeFrame: end of study, at 12 months
measure: Staff Practicality
timeFrame: end of study, at 12 months
measure: Treatment Credibility and Expectancy Questionnaire.
timeFrame: end of study, at 12 months
measure: Resting state functional connectivity (rsFC)
timeFrame: end of study, at 12 months
Secondary outcomes:
measure: National Alzheimer's Coordinating Center (NACC) battery's Number Span
timeFrame: end of study, at 12 months
measure: Paced Auditory Serial Addition Task (PASAT)
timeFrame: end of study, at 12 months
measure: Trail Making Test, Part A
timeFrame: end of study, at 12 months
measure: The Symbol Digit Modalities Text (SDMT)
timeFrame: end of study, at 12 months
measure: The Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: end of study, at 12 months
measure: NACC battery's verbal phonemic and category fluency tests
timeFrame: end of study, at 12 months
measure: NACC battery's abbreviated Multilingual Naming Test (MINT)
timeFrame: end of study, at 12 months
measure: Wide Range Achievement Test, reading subtest, 4th edition (WRAT-4)
timeFrame: end of study, at 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Juan Wisnivesky, MD, DrPh
role: PRINCIPAL_INVESTIGATOR
References: