Long COVID Brain Fog: Cognitive Rehabilitation Trial

Cognitive Impairment Clinical Trial

Official title:

Technique to Enable Return-to-Work by Employees With Long COVID Brain Fog

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095297
• Other study ID #: IRB-300010908
• Secondary ID: 90IFRE0073
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Piper Hempfling, MS
• Phone: 205-934-9768
• Email: pchemp[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare two approaches to cognitive rehabilitation in adults with long COVID with persistent, mild to moderate, cognitive impairment. One approach will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) in-lab training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation (VNS), i.e., trans-auricular VNS (taVNS). Component B will include work-related tasks. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will feature (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, healthy nutrition, and healthy sleep, (C) procedures designed to promote integration of these lifestyle changes into everyday life, and (D) taVNS. This approach is termed Brain Fitness Training (BFT).

A subset of participants, who qualify for and and desire vocational rehabilitation (VR), will receive VR from the Alabama Department of Rehabilitation Services (ADRS) in addition to CICT or BFT. ADRS VR will include career counseling, prescription of on-the-job accommodations, and guidance on return-to-work. Those in the CICT + VR group will also receive on-the-job coaching from a peer mentor for a month after completing training.

CICT, with or without VR, will involve 30 hours of training. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life and improving skills essential to work; the set of the latter procedures is termed the Transfer Package. ta-VNS will administered for 10 minutes before gaming and in-lab target behavior training. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life.

BFT, with or without VR, will involve 30 hours of training following the same schedule as for CICT. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors (healthy sleep, nutrition and relaxation habits) and the procedures designed to promote transfer of behavior change to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life.

Participants will be randomly assigned to the interventions. Randomization will be stratified by whether participants qualify for and desire VR from ADRS or not. If yes, participants will be randomized in equal numbers to CICT + VR or BFT + VR. If no, participants will be randomized in equal numbers to CICT or BFT.

Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Another important outcome measure will be whether or not participants were able to return back to work or had significant improvements in their work activities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >3 months post COVID

• mild or greater cognitive impairment

• moderate or greater brain fog

• impairment in performance of daily activities

• reside in community

• reliable transportation to lab

• sufficiently mentally and physically fit

• adequate sight and hearing

• ability to follow directions, and retain information

• sufficient English proficiency

Exclusion Criteria:

• cognitive impairment due to developmental disability, psychiatric disorder, or substance abuse, TBI or progressive brain disease

• stroke prior to the onset of COVID

• current substance abuse disorder

• prior cognitive processing speed training on DoubleDecision or similar program

• cannot tolerate trans-auricular vagus nerve stimulation

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• COVID-19
• Long COVID
• Mental Fatigue

Intervention

Behavioral:
• Processing Speed Training
Speed of processing training involves trainer-guided practice of computer-based video "games." The games require the "player" to rapidly distinguish targets from decoys, which trains how rapidly the player processes information received through their senses.
• In-lab Instrumental Activities of Daily Living Training
Participant will receive shaping on IADLS. Participants will receive training on everyday tasks with important cognitive components, in which the difficulty is increased in small steps over the course of treatment.
• In-lab Brain Health Training
Participants will receive training on healthy eating, sleeping, and relaxation techniques that have been shown to improve brain health.
• Transfer Package
The Transfer Package was designed to try and bridge the gap between what is trained in the lab and what the participant does outside of the treatment setting. This components includes negotiation of a behavioral contract with participants at the outset of treatment regarding the responsibilities of the participant, family caregivers, if available, and the treatment team, self-monitoring, assignment of "homework," review of homework by the trainer, and support of problem-solving by the participant.
• Follow Up Phone Calls
After completing training, participants will receive four follow up phone calls in the first month of training. Each call will separated by about a week. The focus of the calls will incorporating the lessons learnt during treatment into daily life.
• Vocational Rehabilitation
In partnership with the Alabama Department of Rehabilitation Services (ADRS), participants who are eligible may receive vocational rehabilitation. Participants will receive typical services offered by the ADRS. These could include career counseling, guidance regarding job retention or return-to-work, and guidance regarding workplace accommodations.
• Peer Mentoring
Participants who are eligible for vocational rehabilitation, and agree will also have a peer mentor, a co-worker that will be trained by our team, to reinforce strategies the participant learned during training, and to help the participant problem solve issues that may arise on the job during the first month after treatment. Peer mentors will meet with trainers during the month after treatment to make sure procedures are being followed and address any issues that may arise.
• Reaction Time Training
Reaction time training involves trainer-guided practice of computer-based video "games." Several different games will be featured that train how rapidly "players" react to "threats" and train eye-hand coordination.

Procedure:
• Trans-auricular Vagus Nerve Stimulation: High Intensity
The vagus nerve run from the brain to the external ear, throat, chest, and abdomen and controls, among other functions, the rest and relax response, which supports learning and turns down inflammatory processes. The rest and relax response can be turned on by electrically stimulating the vagus nerve. We will place electrodes on the external part of each ear and safely apply a microcurrent of at least 4 milliamps. Stimulation will administered for 10 minutes near the start and midway point of each treatment session.
• Trans-auricular Vagus Nerve Stimulation: Low Intensity
The vagus nerve run from the brain to the external ear, throat, chest, and abdomen and controls, among other functions, the rest and relax response, which supports learning and turns down inflammatory processes. The rest and relax response can be turned on by electrically stimulating the vagus nerve. We will place electrodes on the external part of each ear and safely apply a microcurrent of less than 4 milliamps. Stimulation will administered for 10 minutes near the start and midway point of each treatment session.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Disability, Independent Living, and Rehabilitation Research, Posit Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canadian Occupational Performance Measure (COPM)	The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview which is commonly used to measure the real-world outcome of rehabilitation procedures that span both motor and cognitive functions after stroke. The Performance Scale assesses how well a participant performs five activities in their daily life, i.e., outside the lab, that are important to the participant. Activities, for this purpose, will be restricted to those with an important cognitive component ,i.e., IADL. The 10-point response scale ranges from 1 (not able to do the activity at all) to 10 (able to do the activity extremely well). Performance Scale scores from the participant will be the primary outcome.	Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment