Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment

Cognitive Impairment Clinical Trial

Official title:

Assessing the Effectiveness of Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498493
• Other study ID #: STUDY-20-00857
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: January 2024

Study information

• Verified date: July 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Nadia Zubair
• Phone: 212.824.7972
• Email: nadia.zubair[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 rehabiliation/training or daily meditative practices during study enrollment

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Behavioral:
• Cognitive Rehabilitation
The virtual small group format will include two to five participants and one facilitator per group. The three individual sessions are distributed at the beginning, middle, and towards the end of the training program. Individual Session 1 occurs after Group Session 1. It covers orientation to the training program, including orientation to and clarification of the Participant Handbook. Individual Session 2 occurs after Group Session 5 and involves review and implementation of training strategies. Individual Session 3 occurs after Group Session 9 and covers review of learned strategies, implementation of training strategies in daily life, and review of execution, obstacles, and adjustments required for individual projects.
• Brain Health Education Program
The active control group will control for non-specific effects inherent to supervised CR. Participants will receive a manualized brain health education (BHE) training program, matched with the adapted CR intervention for therapist time and homework. Once these participants complete the 12 weeks of the control intervention and undergo the post-intervention assessments, participants will be offered the 12 weeks active intervention to ensure that all study participants have the potential of benefitting from CR.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trail Making Test - Part B	Trail Making Test - Part B: a measure of aspects of executive functioning (e.g., set- shifting and cognitive flexibility), where participants connect the dots on a page scattered with numbers and letters in alternating sequence. Scored by time in seconds. Higher number of seconds implies deficiencies in cognitive functioning.	end of study, at 12 months
Primary	Wisconsin Card Sorting Task (WCST)-64	Wisconsin Card Sorting Task (WCST)-64: Computer Version 2. The WCST-64 is a measure of executive functioning assessing novel problem solving and abstract thinking. The software scores the test and generates percentile scores (0-100). Scored by percentile. Higher percentile implies scoring better than others who have completed the task.	end of study, at 12 months
Primary	Acceptability Scale	Acceptability: using 7 Likert-rated items (scores will be coded as: Low: =3; Moderate: 3-3.9; Good: =4).; Full range from 1-7, with higher score indicating higher acceptability.	end of study, at 12 months
Primary	Enrollment yield	Practicality measured by enrollment yield which is #enrolled/approached.	end of study, at 12 months
Primary	Dropout number	Practicality measured by number of dropout	end of study, at 12 months
Primary	Staff Practicality	Open-ended questions to staff regarding challenges conducting intervention (e.g., difficulty enrolling, reaching, engaging participants; scores will be coded as: Low: <50%; Moderate: 50-70%; Good: >70%).	end of study, at 12 months
Primary	Treatment Credibility and Expectancy Questionnaire.	Participants' beliefs about how likely they are to benefit from the intervention using the Treatment Credibility and Expectancy Questionnaire. Full scale from 0-10, with higher score indicating higher treatment expectancy.	end of study, at 12 months
Primary	Resting state functional connectivity (rsFC)	Neuroimaging Outcomes: Resting state functional connectivity (rsFC) within the central executive network (CEN).	end of study, at 12 months
Secondary	National Alzheimer's Coordinating Center (NACC) battery's Number Span	Participants hear digit sequences of increasing lengths and have to recall them forward and in reversed order. Each level contains two equal number series with different numbers. Max score is 14 points for forward span and 14 points for backwards span. Higher score indicates better performance.	end of study, at 12 months
Secondary	Paced Auditory Serial Addition Task (PASAT)	Single digits are presented every 3 seconds and the participant must add each new digit to the one immediately prior to it. The score is the total number correct out of 60 possible answers. Full scale range from 0-60. Higher scores represent better performance.	end of study, at 12 months
Secondary	Trail Making Test, Part A	Requires participants to connect numbered dots in order as quickly as possible. A higher number of seconds implies worse performance.	end of study, at 12 months
Secondary	The Symbol Digit Modalities Text (SDMT)	Requires an individual to substitute digits for abstract symbols using a reference key as quickly as possible. Reaction times in seconds for the performance of the symbol-digit modalities test. A higher number of seconds implies worse performance.	end of study, at 12 months
Secondary	The Hopkins Verbal Learning Test-Revised (HVLT-R)	A list learning task that assesses learning (immediate recall) and memory (delayed recall) and recognition discrimination. The total score (higher score means a better outcome) is converted to a standardized "T" score using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of better performance.	end of study, at 12 months
Secondary	NACC battery's verbal phonemic and category fluency tests	Requires participants to name as many words as they can beginning with a particular letter in 60 seconds, and then as many animals as they can, respectively. A higher number of words or animals named is indicative of better performance.	end of study, at 12 months
Secondary	NACC battery's abbreviated Multilingual Naming Test (MINT)	The MINT is a research measure intended to assess word retrieval deficits. It requires participants to name a series of individually presented line drawings that range from highly common (e.g. butterfly) to more obscure (e.g., axle) objects. The total scores range from 0 to 32, with higher scores indicating better performance.	end of study, at 12 months
Secondary	Wide Range Achievement Test, reading subtest, 4th edition (WRAT-4)	A measure of premorbid intellectual estimate. Scores range from 0-70, where a higher score indicates greater premorbid intellectual ability.	end of study, at 12 months