Cognitive Rehabilitation for Long COVID Brain Fog
Recruiting in Palo Alto (17 mi)
Overseen byGitendra Uswatte, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Developmental disability, Psychiatric disorder, Substance abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment for Long COVID brain fog?
Research suggests that cognitive training, like Speed of Processing Training, can improve cognitive function in conditions such as multiple sclerosis, and similar approaches have shown promise in improving cognitive function in COVID-19 survivors. Additionally, personalized computerized cognitive training has been found to significantly enhance cognitive abilities in people with post-COVID-19 cognitive dysfunction.
12345Is cognitive rehabilitation for Long COVID brain fog safe for humans?
The studies reviewed do not report any specific safety concerns related to cognitive rehabilitation or training for brain fog or cognitive impairment, suggesting it is generally safe for humans.
15678How is the Processing Speed Training and Reaction Time Training treatment unique for Long COVID brain fog?
This treatment is unique because it focuses on improving cognitive functions like processing speed and reaction time through specific cognitive exercises, which is different from other treatments that may not target these specific cognitive skills. Additionally, there are currently no standard treatments for cognitive impairment in Long COVID, making this approach novel.
1491011Eligibility Criteria
Adults with long COVID experiencing mild to moderate cognitive issues, such as brain fog and trouble with daily activities. They must be over 3 months post-COVID, able to travel to the lab, mentally and physically fit enough for participation, have good vision and hearing, follow instructions well, and speak English. Excluded are those with a history of stroke before COVID-19 or current substance abuse.Inclusion Criteria
I struggle with daily activities due to my condition.
I can follow directions and remember information.
I had COVID-19 over 3 months ago.
+7 more
Exclusion Criteria
Current substance abuse disorder
I had a stroke before getting COVID.
I have previously completed a cognitive speed training program like DoubleDecision.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
1 visit (in-person)
Treatment
Participants undergo 30 hours of training over 2 to 4 weeks, including web-based games, in-lab training, and vagus nerve stimulation
2-4 weeks
10 visits (in-person)
Follow-up
Participants receive four follow-up phone calls to promote integration of skills gained during training into everyday life
4 weeks
4 calls (virtual)
Long-term Follow-up
Participants are monitored for cognitive processing speed and performance in everyday activities at 6 and 12 months post-treatment
12 months
2 visits (in-person)
Participant Groups
The trial compares two cognitive rehabilitation methods: Constraint-Induced Cognitive Therapy (CICT) focuses on processing speed training and practical tasks including work-related ones; Brain Fitness Training (BFT) emphasizes reaction time training along with lifestyle habits like relaxation. Both use non-invasive vagus nerve stimulation (taVNS) and may include vocational rehab for eligible participants.
4Treatment groups
Experimental Treatment
Active Control
Group I: CICT + VRExperimental Treatment7 Interventions
Constraint-Induced Cognitive Therapy plus Vocational Rehabilitation uses in-lab training on everyday activities with important cognitive components and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills.
Group II: CICTExperimental Treatment5 Interventions
Constraint-Induced Cognitive Therapy uses in-lab training on everyday activities with important cognitive components and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation.
Group III: BFTActive Control5 Interventions
Brain Fitness Training involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This will be combined with computer-based reaction time training and non-invasive vagus nerve stimulation.
Group IV: BFT + VRActive Control6 Interventions
Brain Fitness Training plus Vocational Rehabilitation involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This will be combined with computer-based reaction time training and non-invasive vagus nerve stimulation. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills.
Processing Speed Training is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Speed of Processing Training for:
- Cognitive impairment in older adults
- Long COVID brain fog
🇨🇦 Approved in Canada as Speed of Processing Training for:
- Cognitive impairment in older adults
- Long COVID brain fog
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
Posit ScienceCollaborator
National Institute on Disability, Independent Living, and Rehabilitation ResearchCollaborator
References
Neuromodulation through brain stimulation-assisted cognitive training in patients with post-COVID-19 cognitive impairment (Neuromod-COV): study protocol for a PROBE phase IIb trial. [2022]A substantial number of patients diagnosed with COVID-19 experience long-term persistent symptoms. First evidence suggests that long-term symptoms develop largely independently of disease severity and include, among others, cognitive impairment. For these symptoms, there are currently no validated therapeutic approaches available. Cognitive training interventions are a promising approach to counteract cognitive impairment. Combining training with concurrent transcranial direct current stimulation (tDCS) may further increase and sustain behavioural training effects. Here, we aim to examine the effects of cognitive training alone or in combination with tDCS on cognitive performance, quality of life and mental health in patients with post-COVID-19 subjective or objective cognitive impairments.
A proposal to apply brain injury recovery treatments for cognitive impairment in COVID-19 survivors. [2022]There is still little information about the nature and broader prevalence of cognitive problems during post-infection in COVID-19 survivors. This is also the case for pathobiological findings related to these complications. In the meantime, there is mounting alarm regarding potential long-term outcomes of COVID-19, with descriptions of 'long COVID' symptoms keeping up into the chronic stage, which include 'brain fog'. The cognitive impairment or brain fog creates many difficulties in daily activities and makes problems for those who wish to successfully return to their job. The author proposes applying brain injury recovery treatments for cognitive impairment in COVID-19 survivors.
The Efficacy of the Speed of Processing Training Program in Improving Functional Outcome: From Restoration to Generalization. [2023]To examine the efficacy of Speed of Processing Training (SOPT) in improving everyday functional outcomes in persons with multiple sclerosis (MS).
Cognitive rehabilitation in post-COVID-19 condition: A study protocol for a randomized controlled trial. [2023]Post-COVID-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (EFs), which can act as a barrier for regaining pre-illness functional levels. Goal Management Training (GMT) is a cognitive rehabilitation (CR) intervention for improving attention and EFs that has received empirical support in studies of other patient groups. The present study aims to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after COVID-19.
Personalized Computerized Training for Cognitive Dysfunction after COVID-19: A Before-and-After Feasibility Pilot Study. [2023]The current pilot study was set to evaluate the feasibility and potential benefit of a personalized computerized cognitive training (CCT) intervention to improve cognitive function among people living with post-acute sequelae of COVID-19 (PASC). Seventy three adults who self-reported cognitive dysfunction more than 3 months after a diagnosis of COVID-19 took part in an 8-week training study. Participants' general cognitive function was assessed before they completed as many cognitive daily training sessions as they wished during an 8-week period, using a personalized CCT application at home. At the end of this period, participants repeated the general cognitive function assessment. The differences between the scores at 8 weeks and baseline in five cognitive domains (attention, memory, coordination, perception, reasoning), complemented with analyses of the changes based on the participants' age, training time, self-reported health level at baseline and time since the initial COVID-19 infection. Participants had significant cognitive dysfunction and self-reported negative health levels at baseline. Most of the participants obtained higher scores after CCT in each of the domains as compared with baseline. The magnitude of this score increase was high across domains. It is concluded that a self-administered CCT based on gamified cognitive tasks could be an effective way to ameliorate cognitive dysfunction in persons with PASC. The ClinicalTrials.gov identifier is NCT05571852.
Neuroimaging and Neuropsychological Outcomes Following Clinician-Delivered Cognitive Training for Six Patients With Mild Brain Injury: A Multiple Case Study. [2020]Nearly half of all mild brain injury sufferers experience long-term cognitive impairment, so an important goal in rehabilitation is to address their multiple cognitive deficits to help them return to prior levels of functioning. Cognitive training, or the use of repeated mental exercises to enhance cognition, is one remediation method for brain injury. The primary purpose of this hypothesis-generating pilot study was to explore the statistical and clinical significance of cognitive changes and transfer of training to real-life functioning following 60 h of Brain Booster, a clinician-delivered cognitive training program, for six patients with mild traumatic brain injury (TBI) or non-traumatic acquired brain injury (ABI). The secondary purpose was to explore changes in functional connectivity and neural correlates of cognitive test gains following the training. We used a multiple case study design to document significant changes in cognitive test scores, overall IQ score, and symptom ratings; and we used magnetic resonance imaging (MRI) to explore trends in functional network connectivity and neural correlates of cognitive change. All cognitive test scores showed improvement with statistically significant changes on five of the seven measures (long-term memory, processing speed, reasoning, auditory processing, and overall IQ score). The mean change in IQ score was 20 points, from a mean of 108 to a mean of 128. Five themes emerged from the qualitative data analysis including improvements in cognition, mood, social identity, performance, and Instrumental Activities of Daily Living (IADLs). With MRI, we documented significant region-to-region changes in connectivity following cognitive training including those involving the cerebellum and cerebellar networks. We also found significant correlations between changes in IQ score and change in white matter integrity of bilateral corticospinal tracts (CST) and the left uncinate fasciculus. This study adds to the growing body of literature examining the effects of cognitive training for mild TBI and ABI, and to the collection of research on the benefits of cognitive training in general. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02918994.
Effects of cognitive speed of processing training on a composite neuropsychological outcome: results at one-year from the IHAMS randomized controlled trial. [2022]Age-related cognitive decline is common and well-documented. Cognitive speed of processing training (SOPT) has been shown to improve trained abilities (Useful Field of View; UFOV), but transfer to individual non-trained cognitive outcomes or neuropsychological composites is sparse. We examine the effects of SOPT on a composite of six equally weighted tests--UFOV, Trail-making A and B, Symbol Digit Modality, Controlled Oral Word Association, Stroop Color and Word, and Digit Vigilance.
Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial. [2022]Higher-order cognitive training has shown to enhance performance in older adults, but the neural mechanisms underlying performance enhancement have yet to be fully disambiguated. This randomized trial examined changes in processing speed and processing speed-related neural activity in older participants (57-71 years of age) who underwent cognitive training (CT, N = 12) compared with wait-listed (WLC, N = 15) or exercise-training active (AC, N = 14) controls. The cognitive training taught cognitive control functions of strategic attention, integrative reasoning, and innovation over 12 weeks. All 3 groups worked through a functional magnetic resonance imaging processing speed task during 3 sessions (baseline, mid-training, and post-training). Although all groups showed faster reaction times (RTs) across sessions, the CT group showed a significant increase, and the WLC and AC groups showed significant decreases across sessions in the association between RT and BOLD signal change within the left prefrontal cortex (PFC). Thus, cognitive training led to a change in processing speed-related neural activity where faster processing speed was associated with reduced PFC activation, fitting previously identified neural efficiency profiles.
The effectiveness of cognitive-motor training on reconstructing cognitive health components in older male adults, recovered from the COVID-19. [2022]The incidence of COVID-19 disease in the elderly can accelerate normal degenerative process of cognitive functions. Interactive cognitive-motor training (CMT) is an intervention that integrates cognitive and motor tasks to promote individuals' physical and psychological health. The present study aimed to examine the effect of CMT on reconstructing cognitive health components in older men, who have recently recovered from COVID-19.
Effects of Computerized Cognitive Training and Tai Chi on Cognitive Performance in Older Adults With Traumatic Brain Injury. [2021]To compare the effects of computerized cognitive training (CCT) and tai chi (TC) with usual care (UC) on cognitive functions and secondary outcomes in older adults with traumatic brain injury.
Long-Term Effect of Cognitive Rehabilitation Regardless of Prerehabilitation Cognitive Status for Veterans with TBI. [2021]Persisting difficulties in executive functioning (EF) are common after traumatic brain injury (TBI). Cognitive rehabilitation can be effective, but the impact of pretreatment neurocognitive functioning on long term effects of rehabilitation is unknown. Because this information can impact treatment planning, we examined the relationship between prerehabilitation neurocognitive status and long-term effects of EF training. Archival data were drawn from a trial of Goal-Oriented Attentional Self-Regulation group-format EF training for Veterans with TBI [mild-severe; 11 years postinjury; 96% male, 32% nonwhite, 14.21 years education (SD 1.72), 41.13 years old (SD 11.39)]. Using prerehabilitation neurocognitive performance, participants were clustered into cognitive difficulty (CD) and cognitively normal (CN) groups. Six-plus months after EF rehabilitation training, participants completed a structured telephone interview and/or in-person cognitive/functional/emotional assessment using standardized measures of cognitive, daily, and emotional functioning frequently employed in TBI research. At 6+ months post-EF training compared to prerehabilitation, CD and CN improved in multiple cognitive (Overall Attention/EF: F(1,18) = 26.17, partial η2 = .59; Total Memory: F(1,18) = 6.82, partial η2 = .28) and functional domains (Goal Processing Scale [GPS] total score: F(1,15) = 6.71, partial η2 = .31). CD improved more than CN on Learning and Memory functional domain [F(1,15) = 6.10, partial η2 = .29]. Results of our small archival analysis raise the possibility that Veterans with chronic TBI may demonstrate long-term effects of EF training.