Brain Training for Spinal Cord Injury

(SCI-IQ Trial)

Recruiting at 2 trial locations

Overseen By Erica Weber

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Neurological, psychiatric, substance use, others

Compensation: Varies

Number of Visits: 38

Duration: 12 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a cognitive training program can improve the thinking speed of individuals with recent spinal cord injuries. Participants will engage in game-like computer exercises three times a week for 12 weeks. Some will perform these specific activities, while others will complete placebo tasks for comparison. This trial suits adults who experienced a traumatic spinal cord injury within the last six months and do not have other major neurological conditions. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance cognitive recovery strategies.

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

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

What prior data suggests that this cognitive training program is safe for individuals with spinal cord injury?

Research has shown that game-like computer activities are generally safe for people with spinal cord injuries. Studies have found that similar computer-based exercises, such as virtual reality rehab, are well-tolerated and can enhance physical abilities without causing harm. For instance, one study found that virtual reality training improved walking and balance in people with spinal cord injuries, with no serious side effects reported.

Although this specific cognitive training program is new, the use of computer games for rehab has a history of safety. The activities involve repeating specific tasks, which are typically low-risk. Studies of these activities have reported no serious problems, suggesting they are safe to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this brain training method for spinal cord injury because it offers a novel, non-invasive approach that aims to improve cognitive function through game-like computerized activities. Unlike traditional treatments that focus primarily on physical rehabilitation, this method leverages cognitive training to potentially enhance neural pathways and brain plasticity. By engaging patients in regular, structured cognitive exercises, it could offer an innovative way to support overall recovery and improve quality of life, addressing an aspect often overlooked by standard physical therapies.

What evidence suggests that this cognitive training program is effective for improving processing speed in spinal cord injury?

Research has shown that game-like computer activities, which participants in this trial may receive, can help improve thinking skills. Studies have found that these digital games can enhance cognitive speed in people with spinal cord injuries. For example, one study on brain injuries found that serious games for mental exercises can be beneficial. Another study demonstrated that digital games could improve thinking skills and overall well-being. These findings suggest that the computer activities in this trial might help people with spinal cord injuries think more quickly. ^{4 6 7 8 9}

Who Is on the Research Team?

Erica Weber, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-59 who have recently experienced a traumatic spinal cord injury, approximately within the last 6 months. It's designed to help those facing cognitive impairments due to their injury.

Inclusion Criteria

My spinal cord injury happened about 6 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in pre-specified computer tasks using an Internet-based cognitive training portal, 3 times per week for 60 minutes each session

12 weeks

36 sessions (virtual)

Immediate Post-Treatment Assessment

Assessment of cognitive processing speed using SDMT, UFOV, and LPC tasks

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for long-term effects on cognitive processing speed and quality of life

12 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• game-like computerized activities
• Placebo

Trial Overview

The study is testing if game-like computerized activities can speed up how fast patients with acute spinal cord injuries process information. Some participants will use these activities while others will receive a placebo as a comparison.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

pre-specified computer tasks using an Internet-based cognitive training portal, to be completed 3x per week for 60 minutes each session for 12 weeks total

Group II: Placebo Control Placebo Group 1 Intervention

pre-specified computer tasks using an Internet-based cognitive training portal, to be completed 3x per week for 60 minutes each session for 12 weeks total

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Craig Hospital

Collaborator

Trials

45

Recruited

8,400+

Published Research Related to This Trial

Combining traditional trunk control training with iPad game apps led to significant improvements in trunk control for patients with low thoracic spinal cord injuries, as evidenced by increased scores on both game performance and the Trunk Recovery Scale.

Patients reported positive experiences with the rehabilitation approach, indicating that the use of technology in therapy can enhance motivation and engagement in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tablet Technology for Rehabilitation after Spinal Cord Injury: a Proof-of-Concept. Fizzotti, G., Rognoni, C., Imarisio, A., et al.[2016]

In a study of 42 spinal cord injury patients, those who underwent semi-immersive virtual reality cognitive training showed significant improvements in global cognitive functioning, mood, and quality of life compared to those receiving traditional therapy.

The results suggest that integrating cognitive exercises with movement and feedback in virtual reality can enhance both cognitive and motor recovery in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Individuals with Spinal Cord Injury Benefit from Semi-Immersive Virtual Reality Cognitive Training? Preliminary Results from an Exploratory Study on an Underestimated Problem. Maggio, MG., Bonanno, M., Manuli, A., et al.[2023]

A 60-year-old man with incomplete cervical spinal cord injury showed significant improvements in cognitive function, anxiety, and motor performance after a combined rehabilitation approach that included virtual reality training.

The use of virtual reality rehabilitation systems (VRRS) demonstrated effectiveness in enhancing recovery for patients with both motor and cognitive deficits, suggesting it could be a valuable tool in neurological rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel use of virtual reality in the treatment of cognitive and motor deficit in spinal cord injury: A case report. Maresca, G., Maggio, MG., Buda, A., et al.[2022]

The mobile game-based VR rehabilitation program (MoU-Rehab) significantly improved upper extremity function in stroke patients compared to conventional therapy, as measured by the Fugl-Meyer Assessment and other metrics.

The program was well-tolerated with no adverse effects reported, and patients expressed high satisfaction, indicating its feasibility as a rehabilitation tool for upper limb recovery after ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Choi, YH., Ku, J., Lim, H., et al.[2019]

Intensive virtual reality (VR)-augmented training over 4 weeks significantly improved balance, walking speed, ambulation, and muscle strength in nine patients with incomplete spinal cord injury (iSCI), with benefits retained for 3-4 months after training.

Longitudinal MRI analysis revealed structural brain plasticity in iSCI patients, showing volume increases in several brain regions, indicating that VR training not only enhances motor function but also induces measurable changes in brain structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between structural brainstem and brain plasticity and lower-limb training in spinal cord injury: a longitudinal pilot study. Villiger, M., Grabher, P., Hepp-Reymond, MC., et al.[2022]

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]

The study involving 22 adults with shoulder pathologies found that the digital therapy using Playball® was as effective as traditional non-digital therapy in improving pain, strength, and overall shoulder function after ten rehabilitation sessions.

Patients using the digital therapy reported higher engagement levels, with significant improvements in self-efficacy and positive attitudes towards home training, suggesting that this approach may enhance long-term exercise adherence post-rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and therapeutic compliance of digital therapy in shoulder rehabilitation: a randomized controlled trial. Rizzato, A., Pizzichemi, M., Gobbi, E., et al.[2023]

A rehabilitation protocol using a center-of-pressure-controlled video game tool significantly improved dynamic short-sitting balance in three adults with spinal cord injuries and traumatic brain injury, indicating its efficacy as a therapeutic intervention.

The use of video game-based exercises increased patient motivation and engagement, leading to higher practice volume and attention span during training, which are crucial for effective rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Game-based exercises for dynamic short-sitting balance rehabilitation of people with chronic spinal cord and traumatic brain injuries. Betker, AL., Desai, A., Nett, C., et al.[2009]

A 71-year-old woman with neuropathic pain after cervical spinal cord injury showed significant improvement in brain activity (event-related desynchronization) after 4 months of brain-computer interface (BCI) training.

The patient's pain levels decreased from a visual analog scale score of 8 to 5, suggesting that BCI training may help alleviate persistent neuropathic pain and enhance quality of life through brain plasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relief of neuropathic pain after spinal cord injury by brain-computer interface training. Yoshida, N., Hashimoto, Y., Shikota, M., et al.[2022]

Cognitive rehabilitation for brain-injured patients is increasingly utilizing computer-assisted therapy, with 73% of surveyed rehabilitation centers incorporating computers to address various cognitive deficits such as attention, memory, and problem-solving.

Effective computer-assisted therapy requires careful supervision by therapists, including detailed patient assessments and individualized software adaptations to optimize treatment outcomes, particularly during rehabilitation and post-rehabilitation phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Microcomputer and rehabilitation of cognitive cerebral performance disorders]. Schönle, PW., Wiebold, G., Wieding, J., et al.[2015]

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Brain Training for Spinal Cord Injury (SCI-IQ Trial)

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A Computer game-assisted Tele-Rehabilitation Platform (GTP) has been developed to address this need. With the novel application of a miniature ...