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

Trial Summary

What is the purpose of this trial?

This study seeks conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury.

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 data supports the effectiveness of the treatment involving game-like computerized activities for spinal cord injury?

Research shows that using virtual reality and game-based exercises can improve cognitive and motor functions in people with spinal cord injuries. Patients who participated in these activities reported better mood, quality of life, and physical perception compared to those who received traditional therapy. ^{1 2 3 4 5}

Is brain training for spinal cord injury safe for humans?

Research on computerized cognitive training programs, like RehaCom, has shown that they are generally safe, with some patients experiencing mild side effects such as mental fatigue, headache, and eye irritation. ^{1 3 6 7 8}

How does the brain training treatment for spinal cord injury differ from other treatments?

This brain training treatment uses game-like computerized activities to improve cognitive and motor functions in spinal cord injury patients, which is different from traditional therapies that may not incorporate interactive or virtual reality elements. It combines cognitive exercises with movement, providing increased feedback and engagement, potentially leading to better recovery outcomes. ^{1 3 4 9 10}

Research Team

Erica Weber, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

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

I am between 18 and 59 years old.

My spinal cord injury happened about 6 months ago.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Switzerland 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. [2023]

2. United States 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. [2022]

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

Game-based exercises for dynamic short-sitting balance rehabilitation of people with chronic spinal cord and traumatic brain injuries. [2009]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Tablet Technology for Rehabilitation after Spinal Cord Injury: a Proof-of-Concept. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

[Microcomputer and rehabilitation of cognitive cerebral performance disorders]. [2015]

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

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. [2019]

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

Effectiveness and therapeutic compliance of digital therapy in shoulder rehabilitation: a randomized controlled trial. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship between structural brainstem and brain plasticity and lower-limb training in spinal cord injury: a longitudinal pilot study. [2022]

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

Relief of neuropathic pain after spinal cord injury by brain-computer interface training. [2022]