30 Participants NeededMy employer runs this trial

Cognitive Rehabilitation for Brain Fog

NG
HB
MR
Overseen ByMadeline Rathz, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help individuals with post-viral brain fog improve their thinking skills. One method uses computer games to speed up brain processing and includes exercises for everyday tasks. The other method focuses on reaction time, relaxation, and healthy habits. Both methods incorporate a non-invasive technique called trans-auricular vagus nerve stimulation (taVNS), which gently stimulates a nerve to aid brain function. Individuals who have experienced ME/CFS, a condition causing long-term fatigue and cognitive issues, and who experience brain fog affecting daily activities might be suitable candidates. Participants should be able to visit the lab for tests, have internet access, and feel comfortable with online sessions. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cognitive recovery strategies.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Constraint-Induced Cognitive Therapy (CICT) is generally well-received and may help reduce brain fog in people with long COVID. In earlier studies, participants adhered to the therapy and expressed satisfaction with the results, indicating that CICT is safe to use.

Trans-auricular Vagus Nerve Stimulation (taVNS) is another treatment under investigation. Studies have found that taVNS is a safe and non-invasive method to enhance thinking skills. It has been used in individuals with mild memory or cognitive issues without major side effects.

Both CICT and taVNS have undergone sufficient study to suggest they are safe for people, with only a small risk of side effects reported.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for brain fog because they explore innovative ways to enhance cognitive function through non-invasive means. The CICT + taVNS approach combines Constraint-Induced Cognitive Therapy with computer-based processing speed training and non-invasive vagus nerve stimulation (taVNS), aiming to transfer cognitive improvements to everyday life. Meanwhile, the BFT + taVNS strategy integrates Brain Fitness Training focused on relaxation, nutrition, and sleep with reaction time training and taVNS. Unlike standard medications that often target symptoms, these methods potentially offer holistic improvements by engaging the brain directly and promoting healthy lifestyle changes.

What evidence suggests that this trial's treatments could be effective for brain fog?

Research has shown that Constraint-Induced Cognitive Therapy (CICT), one of the treatments in this trial, can significantly alleviate brain fog and enhance daily life. Studies have found that participants who underwent CICT experienced reduced brain fog and improved performance in everyday activities. In one study, CICT improved thinking skills more effectively than usual treatments.

Brain Fitness Training (BFT) is another treatment option in this trial and shows promise for enhancing cognitive function. It includes exercises that enhance reaction speed and improve eye-hand coordination. Similar training has been linked to a lower risk of dementia and better brain health over time. Both CICT and BFT in this trial incorporate a gentle technique called non-invasive vagus nerve stimulation (taVNS), which may further enhance cognitive benefits.678910

Who Is on the Research Team?

GU

Gitendra Uswatte, PhD

Principal Investigator

Professor of Psychology, University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults (18+) with moderate or worse brain fog and mild or greater cognitive problems linked to ME/CFS, who live in the community, have internet access and a computer/tablet, can travel to the lab several times, and are medically stable. People with seizures, certain heart issues, implanted devices, substance abuse history, pregnancy/breastfeeding, or other major health concerns can't join.

Inclusion Criteria

Moderate or greater brain fog
I have the thinking skills needed to complete attention and learning tests.
Has Internet service
See 10 more

Exclusion Criteria

I have a history of seizures or epilepsy.
Vasovagal syncope or history of fainting
Cognitive impairment due to a developmental disability, psychiatric disorder, substance abuse, or another type of brain injury
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants undergo cognitive rehabilitation training using either CICT or BFT approaches, including web-based games and taVNS, over a secure telehealth platform

2-4 weeks
3 visits (in-person) for blood sample collection and brain imaging

Follow-up

Participants receive 4 follow-up phone calls to promote integration of skills into everyday life

4 weeks
4 phone calls

What Are the Treatments Tested in This Trial?

Interventions

  • Follow Up Phone Calls
  • In-session Brain Health Training
  • In-session Instrumental Activities of Daily Living Training
  • Processing Speed Training
  • Reaction Time Training
  • Trans-auricular Vagus Nerve Stimulation (taVNS)
  • Transfer Package

Trial Overview

The study compares two types of online cognitive rehab programs—Constraint-Induced Cognitive Therapy (CICT) and Brain Fitness Training (BFT)—both including web-based games and non-invasive ear nerve stimulation (taVNS). Participants are randomly assigned to one group. Most sessions happen via telehealth over 2-4 weeks; some in-person visits are required.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CICT + taVNSExperimental Treatment5 Interventions
Group II: BFT + taVNSActive Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Posit Science Corporation

Industry Sponsor

Trials
40
Recruited
4,400+

UAB College of Arts and Sciences & Department of Psychology

Collaborator

Citations

Physical Activity to Counter Age-Related Cognitive Decline

The study results indicated significant improvements in cognitive functions, such as spatial memory, increased anterior hippocampal volume, and ...

Effects of human concurrent aerobic and resistance ...

The findings indicate that CT significantly enhances cognitive health, particularly in older adults and clinical populations.

CogniFit: Brain Training | Trusted by Doctors

Enhance your brain with CogniFit, #1 Doctor trusted brain training for memory, focus, math and more. Start training now!

Cognitive Speed Training Linked to Lower Dementia ...

Additionally, those who completed speed training had a 29% lower incidence of dementia 10 years later compared to the control group. Each ...

Exercising the brain has been proposed as one of the ...

Exercising the brain has been proposed as one of the important tools that can help to decrease chances of developing cognitive decline.

Long COVID Brain Fog Treatment: Findings from a Pilot ... - PMC

Constraint-Induced Cognitive Therapy (CICT) is a new rehabilitation method persistent brain fog accompanied by mild cognitive impairment and IADL dysfunction.

Long COVID Brain Fog Treatment: Feasibility Metrics from ...

This study's objectives were to evaluate the feasibility of a new rehabilitation approach, Constraint-Induced Cognitive Therapy (CICT), for post-COVID-19 ...

Long COVID Brain Fog Treatment: An Early-phase ...

Constraint-Induced Cognitive Therapy (CICT) is a new rehabilitation method that our laboratory has applied to stroke survivors with mild-to-moderate cognitive ...

Constraint-Induced Cognitive Therapy Found to Improve ...

Constraint-induced cognitive therapy (CICT), was found to improve brain fog and other symptoms associated with long

Long COVID Brain Fog Treatment: Findings from a Pilot ...

CICT has promise for reducing brain fog, improving IADL, and promoting returning-to-work in adults with Long COVID. Findings warrant a large- ...