Cognitive Computerized Training for Cognitive Impairment

(CCT Trial)

Overseen By Kayla M Riera, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Substance abuse, Neurodegenerative disorder, Severe cognitive disorder, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a Computerized Cognitive Training program can boost brain function, particularly for individuals with attention and executive functioning challenges or mild cognitive issues. It targets those who experienced a brain injury at least a year ago and face difficulties with tasks requiring attention or planning. Participants must be part of the Mass General Brigham Health System, fluent in English, and able to attend in-person visits in Boston. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cognitive rehabilitation strategies.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe?

Research has shown that Computerized Cognitive Training (CCT) can improve thinking skills. One review found that CCT might enhance overall brain function in individuals with mild memory and thinking problems. Another study found that CCT could improve memory after a stroke, although more research is needed to understand its effectiveness alongside other treatments. A combined analysis of several studies also linked CCT to better thinking and daily skills in people living with HIV.

Regarding safety, no reports of serious side effects have emerged from using CCT, as it involves exercises on a computer or tablet. Since this trial is not in its early stages, this suggests the treatment is generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Computerized Cognitive Training because it offers a unique, interactive approach to improving cognitive function. Unlike traditional treatments for cognitive impairment, which might include medication or standard cognitive exercises, this method uses engaging, technology-based tasks tailored to target specific cognitive skills. This digital format is not only more accessible and flexible but also allows for personalized training programs that can adapt in real-time to a user's performance. By leveraging technology, it has the potential to make cognitive rehabilitation more efficient and enjoyable for patients.

What evidence suggests that Computerized Cognitive Training is effective for cognitive impairment?

Research has shown that Computerized Cognitive Training (CCT), the treatment under study in this trial, can improve thinking skills in people with mild cognitive impairment (MCI). Studies have found that CCT enhances overall brain function, focus, and decision-making abilities. A review of multiple studies found that CCT significantly boosts mental performance, especially in older adults with MCI. Additionally, CCT has been linked to a better quality of life for patients with cognitive issues after a stroke. While researchers continue to study the long-term effects, early results are promising for improving mental skills. ^{1 6 7 8 9}

Who Is on the Research Team?

Kim C Willment, PhD

Principal Investigator

Brigham and Women's Hospital

Kirk R Daffner, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 25-65 with attention and executive functioning issues or mild cognitive disorders from brain injuries at least a year old. Participants must speak English, be able to visit Brigham and Women's Hospital in Boston for assessments, have internet access, and provide an informant to report on their daily functioning.

Inclusion Criteria

You need someone who can answer questions about how you think and function in daily life at four different times during the study.

You can commit to participating in the study for a year and can travel to Brigham and Women's Hospital in Boston for several visits and sample collections.

You need to have a computer with a working camera and reliable internet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in intensive Computerized Cognitive Training using the ABI Wellness BEARS platform and Brainex Software Symbol Relations Module

6 months

5 days per week

Follow-up

Participants are monitored for changes in cognitive outcome measures, BDNF levels, and other neurocognitive markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computerized Cognitive Training

Trial Overview The study examines how well people with cognitive impairments due to brain injury can improve after doing intensive computerized cognitive training. It looks at what factors make the training more effective over a period of 12 months.

How Is the Trial Designed?

Group I: Computerized Cognitive Training Experimental Treatment 1 Intervention

See section of intervention/treatment for additional information.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Fujifilm

Industry Sponsor

Trials

4

Recruited

2,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9650579/

Effectiveness of Computerized Cognitive Training in ... This systematic review suggests that CCT interventions could improve global cognitive function in patients with MCI.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6701629/

a systematic review and meta-analysis - PMC - PubMed Central This meta-analysis provides evidence that CCT improves cognitive function in older people with MCI. However, the long-term transfer of these improvements

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178125004342

Effect of Computerized Cognitive Remediation Therapy ... Meta-analyses have shown that cognitive remediation interventions can substantially improve cognitive performance and functional outcomes ( ...

4. jmir.org jmir.org/2025/1/e73140

The Effectiveness of Computerized Cognitive Training in ... We conclude that CCT can significantly enhance general cognitive function, attention, executive function, and quality of life in PSCI patients.

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1531688/full

Effectiveness of a home-based computerized cognitive ... This study aimed to assess the effectiveness of a Home-Based Computerized Cognitive Training (HB-CCT) program in individuals with PD using a pilot randomized ...

6. jmir.org jmir.org/2022/10/e38624/

Effectiveness of Computerized Cognitive Training in ... This systematic review suggests that CCT interventions could improve global cognitive function in patients with MCI.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451902218301599

Review Controversies in Computerized Cognitive Training Recent reviews presenting negative conclusions about CCT efficacy have inconsistent definitions of the treatment targets and cognitive improvement.

8. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-024-03813-x

The effect of computerized cognitive training and transcranial ... CCT appears to be a suitable choice to enhance WM span performance after stroke. However, further research is needed to investigate the effect of tDCS.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2789577

Evaluation of Computerized Cognitive Training and ... This meta-analysis found that CCT programs were associated with improvements in cognitive and daily function among people living with HIV.