Cognitive Task Performance During Fatigue

Overseen By Hugo Pereira

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Metal implants, joint replacement, neuromuscular disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will study how doing a mental task affects muscle fatigue during exercise. It involves general individuals and aims to see if mental effort changes how tired muscles get.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Cognitive Task, Cognitive Training, Cognitive Remediation, Cognitive Rehabilitation, Cognitive Stimulation Therapy?

Research shows that cognitive rehabilitation, which includes cognitive training and remediation, is effective in improving attention, memory, and other cognitive functions in patients with brain injuries and multiple sclerosis. Studies have demonstrated significant improvements in cognitive performance and everyday behaviors after using computer-assisted cognitive training programs. ^{1 2 3 4 5}

Is cognitive training safe for humans?

Cognitive training, used in various conditions like brain injury and cancer, is generally safe for humans. Some studies noted minor side effects such as mental fatigue, headache, and eye irritation, but overall, participants showed improved cognitive functions without significant safety concerns. ^{1 6 7 8 9}

How does this treatment for cognitive task performance during fatigue differ from other treatments?

This treatment is unique because it focuses on cognitive training using a novel game called 'Decoder' on an iPad, which enhances attention without medication. Unlike traditional drug treatments like methylphenidate, which is used for mental fatigue after brain injury, this approach is non-pharmacological and aims to improve sustained attention through engaging and motivating tasks. ^{10 11 12 13 14}

Research Team

Hugo Pereira, PhD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for healthy individuals in two age groups: young adults aged 18-35 and older adults aged 65-90. It's not suitable for those with neuromuscular diseases or anyone who has metal implants or joint replacements.

Inclusion Criteria

I am healthy and aged 18-35 or 65-90.

Exclusion Criteria

I have a history of muscle or nerve diseases.

History of metal implants or joint replacement

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Familiarization

Participants undergo a familiarization session to get accustomed to the experimental procedures

1 session

1 visit (in-person)

Experimental Sessions

Participants engage in 3 randomized experimental sessions to assess force, anxiety levels, arterial pressure, and fatigue

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for any delayed effects or additional data collection after the experimental sessions

2-4 weeks

Treatment Details

Interventions

• Cognitive Task

Trial Overview The study is examining how performing a cognitive task can affect fatigue during muscle contractions, which might help understand the impact of aging on mental and physical performance.

Participant Groups

Group I: young women Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Group II: young men Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Group III: older women Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Group IV: older men Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Findings from Research

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

In a study involving 15 severely head-injured patients, computer-assisted training for attention and memory showed significant improvements in both computerized tasks and everyday behavior ratings after up to 20 hours of tailored exercises.

The training utilized the THINKable program, which effectively addressed individual needs, leading to measurable enhancements in attention and memory as assessed by psychometric measures and observer ratings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy study of THINKable in the attention and memory retraining of traumatically head-injured patients. Ruff, R., Mahaffey, R., Engel, J., et al.[2019]

Cognitive rehabilitation (CR) has been identified as a potentially effective method for treating cognitive impairments, particularly memory and attention issues, in patients with epilepsy, based on a review of 18 studies.

A holistic approach to CR was found to be more beneficial than selective interventions, highlighting the importance of treatment modalities and outcome measures in clinical practice and research for epilepsy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in epilepsy: An evidence-based review. Farina, E., Raglio, A., Giovagnoli, AR.[2022]

Cognitive rehabilitation is a structured intervention that helps individuals recover cognitive skills after a brain injury, using tailored treatment plans based on thorough neuropsychological assessments.

It has been shown to be effective for a range of cognitive impairments, from mild to severe injuries, and can lead to significant improvements in cognitive abilities and overall psychosocial functioning at any time after the injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation following traumatic brain injury: assessment to treatment. Tsaousides, T., Gordon, WA.[2009]

In a study involving 62 patients with multiple sclerosis, a computer-assisted neuropsychological training program significantly improved cognitive functions such as verbal memory, working memory, and phonetic fluency over 3 months compared to a control group.

The training also led to a notable reduction in anxiety symptoms and an improvement in quality of life for the patients, highlighting its potential benefits beyond cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a short cognitive training program in patients with multiple sclerosis. Pérez-Martín, MY., González-Platas, M., Eguía-Del Río, P., et al.[2020]

Intellectual Function Training (IFT) is an occupational therapy method designed for cognitive retraining in patients with brain damage, focusing on enhancing various intellectual abilities such as visual perception, memory, and logical reasoning.

The IFT program involves systematic, individualized daily treatment over 2-4 months, utilizing comprehensive training materials based on neuropsychological and pedagogical principles to effectively remediate cognitive dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intellectual Function Training in adults with acquired brain damage. An occupational therapy method. Söderback, I., Normell, LA.[2006]

Cognitive training has been shown to significantly improve subjective cognitive function and certain objective cognitive skills, such as working memory and episodic memory, in breast cancer patients experiencing cognitive changes, based on a systematic review of 9 randomized controlled trials involving 666 patients.

Despite these improvements, cognitive training did not lead to significant changes in attention, short-term memory, executive function, or psychological outcomes like anxiety and depression, indicating that while cognitive training can be beneficial, it may not address all cognitive and emotional challenges faced by these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. Yan, X., Wei, S., Liu, Q.[2023]

Computerized cognitive training (CCT) shows strong evidence for improving processing speed in individuals with multiple sclerosis and moderate evidence for enhancing memory in both multiple sclerosis and brain tumor patients, based on a systematic review of 96 studies.

Despite the large number of studies on CCT, only 14 provided high-quality evidence (Level 1), and most outcomes focused on mental functions rather than activities or participation, suggesting a need for more comprehensive measures to assess the full impact of CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised cognitive training in acquired brain injury: A systematic review of outcomes using the International Classification of Functioning (ICF). Sigmundsdottir, L., Longley, WA., Tate, RL.[2018]

In a study of 103 brain-injured patients, over half (50.5%) were cleared to drive upon discharge, with better cognitive retraining performance linked to this driving clearance.

Factors such as effective cognitive retraining in areas like information processing and attention, along with strong working alliance scores with staff, were associated with improved chances of being cleared to drive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship of cognitive retraining to neurological patients' driving status: the role of process variables and compensation training. Klonoff, PS., Olson, KC., Talley, MC., et al.[2019]

In a study of 101 individuals with first-time traumatic brain injury (TBI), mental fatigue was found to significantly mediate the relationship between cognitive functions, specifically recognition memory and information processing speed, and the ability to return to productive activity.

Mental fatigue accounted for a notable portion of the impact of cognitive deficits on returning to work or daily activities, suggesting that addressing mental fatigue could be an important strategy in rehabilitation for TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental fatigue mediates the relationship between cognitive functions and return to productive activity following traumatic brain injury: a mediation analysis. Chen, PY., Hsieh, SH., Lin, CK., et al.[2022]

A follow-up study over 5.5 years showed that methylphenidate significantly improved mental fatigue, depression, anxiety, and processing speed in patients with mild traumatic brain injury (TBI), compared to those who did not receive the treatment.

Discontinuing methylphenidate led to a significant worsening of symptoms, indicating that ongoing treatment may be necessary for sustained improvement in cognitive function after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up after 5.5 years of treatment with methylphenidate for mental fatigue and cognitive function after a mild traumatic brain injury. Johansson, B., Andréll, P., Rönnbäck, L., et al.[2021]

Transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) significantly improved cognitive performance in multiple sclerosis (MS) patients by increasing P300 amplitude and reducing reaction times during cognitive tasks.

The study provides evidence that tDCS can effectively counteract cognitive fatigue in MS patients, suggesting it may be a promising therapeutic option for managing fatigue-related cognitive declines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological and behavioral effects of frontal transcranial direct current stimulation on cognitive fatigue in multiple sclerosis. Fiene, M., Rufener, KS., Kuehne, M., et al.[2018]

Cognitive remediation (CR) has been shown to effectively improve cognitive deficits in individuals with psychiatric disorders, which can enhance daily functioning and potentially influence the course of their illness.

To optimize CR interventions, it is recommended that they be engaging and motivating, utilize positive emotional stimuli, and connect training tasks to real-life situations, while also considering the potential positive effects on overall symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Remediation in Psychiatric Disorders: State of the Evidence, Future Perspectives, and Some Bold Ideas. Trapp, W., Heid, A., Röder, S., et al.[2022]

Cognitive training using the game 'Decoder' significantly improved sustained visual attention in 75 healthy young adults compared to control groups, as measured by the Cambridge Neuropsychological Test Automated Battery.

Participants who played Decoder reported higher enjoyment, motivation, and alertness, suggesting that this non-pharmacological approach could be beneficial for enhancing attention, potentially extending its use to individuals with attention-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in Attention Following Cognitive Training With the Novel "Decoder" Game on an iPad. Savulich, G., Thorp, E., Piercy, T., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy study of THINKable in the attention and memory retraining of traumatically head-injured patients. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in epilepsy: An evidence-based review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation following traumatic brain injury: assessment to treatment. [2009]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of a short cognitive training program in patients with multiple sclerosis. [2020]

6. Sweden pubmed.ncbi.nlm.nih.gov

Intellectual Function Training in adults with acquired brain damage. An occupational therapy method. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Computerised cognitive training in acquired brain injury: A systematic review of outcomes using the International Classification of Functioning (ICF). [2018]

9. England pubmed.ncbi.nlm.nih.gov

The relationship of cognitive retraining to neurological patients' driving status: the role of process variables and compensation training. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Mental fatigue mediates the relationship between cognitive functions and return to productive activity following traumatic brain injury: a mediation analysis. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Follow-up after 5.5 years of treatment with methylphenidate for mental fatigue and cognitive function after a mild traumatic brain injury. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Electrophysiological and behavioral effects of frontal transcranial direct current stimulation on cognitive fatigue in multiple sclerosis. [2018]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Remediation in Psychiatric Disorders: State of the Evidence, Future Perspectives, and Some Bold Ideas. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Improvements in Attention Following Cognitive Training With the Novel "Decoder" Game on an iPad. [2022]