Spinal Cord InjuriesSCI-IQNCT06452264
Early Intervention for Information Processing Speed Deficits in Acute SCI: A Pilot Study
A study testing game-like computerized activities in people with Spinal Cord Injuries and Cognitive Dysfunction, run by Kessler Foundation at 1 site in United States.
Trial summary
This study seeks to conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Cognitive Dysfunction, Cognitive Impairment
- What is being tested?
- game-like computerized activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- recent traumatic SCI (approximately 6 months post-injury)
Who cannot join
- no other significant neurological, psychiatric or substance use history
- no significantly impairing visual disturbance
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Sean Wallace, 973-324-8441, swallace@kesslerfoundation.org
Rebeca Costa, rcosta@kesslerfoundation.org
About this study
This study seeks to conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury.
Read the detailed description
Spinal cord injury (SCI) newly affects approximately 18,000 persons in the US per year. Decades of research have focused on the physical limitations associated with SCI, as well as therapies for addressing these physical problems. However, it is becoming better acknowledged that many individuals experience significant problems with their cognitive abilities, such as attention, memory, and the time it takes them to process information. Research has shown that people who have cognitive difficulties, compared to those with a purely physical disability, are less likely to be employed, engage in fewer social and work-related activities, have greater difficulties carrying out routine household tasks, and are at higher risk for mental illness. If cognitive issues arise after an SCI, it is more likely that a person would have a more challenging time adapting the many lifestyle changes brought about by their injury, would benefit less from their rehabilitation program, and have more difficulty rejoining the workforce. As it stands, cognitive assessment or rehabilitation is not part of the standard of care for individuals after their SCI because of the relative lack of research in this area. This study seeks to conduct a multisite pilot study to test whether a cognitive training program can improve processing speed abilities in individuals shortly after they experience their SCI, with the hopes that this early intervention will improve the trajectory of their overall health and well-being.
- Conditions
- Spinal Cord Injuries, Cognitive Dysfunction, Cognitive Impairment, Acute Spinal Cord Injury
- Being tested
- game-like computerized activities
- Keywords
- processing speed
- Medical subject headings
- Spinal Cord Injuries, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
game-like computerized activitiesBehavioural
game-like computerized activities
game-like computerized activitiesBehavioural
game-like computerized activities
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 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 Receives: Behavioral: game-like computerized activities |
| Placebo Control | Placebo comparator | 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 Receives: Behavioral: game-like computerized activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Useful Field of View (UFOV)
computerized processing speed task
Measured: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Letter and Pattern Comparison (LPC)
processing speed task, using both letter and pattern strings
Measured: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Symbol Digit Modalities Test (SDMT)
processing speed task, matching numbers to symbols using a key
Measured: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Secondary outcomes (1)
Spinal Cord Injury Quality of Life scales (SCI-QOL)
self-reported instruments of quality of life after SCI
Measured: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start19 Jun 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica Weber, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452264
- Sponsor's protocol ID
- R-1225-23
- Acronym
- SCI-IQ
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for Information Processing Speed Deficits in Acute SCI: A Pilot Study
- ClinicalTrials.gov ID
- NCT06452264
- Acronym / sponsor ID
- SCI-IQ / R-1225-23
- Conditions
- Spinal Cord Injuries, Cognitive Dysfunction, Cognitive Impairment, Acute Spinal Cord Injury
- Keywords
- processing speed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury.
Detailed description
Spinal cord injury (SCI) newly affects approximately 18,000 persons in the US per year. Decades of research have focused on the physical limitations associated with SCI, as well as therapies for addressing these physical problems. However, it is becoming better acknowledged that many individuals experience significant problems with their cognitive abilities, such as attention, memory, and the time it takes them to process information. Research has shown that people who have cognitive difficulties, compared to those with a purely physical disability, are less likely to be employed, engage in fewer social and work-related activities, have greater difficulties carrying out routine household tasks, and are at higher risk for mental illness. If cognitive issues arise after an SCI, it is more likely that a person would have a more challenging time adapting the many lifestyle changes brought about by their injury, would benefit less from their rehabilitation program, and have more difficulty rejoining the workforce. As it stands, cognitive assessment or rehabilitation is not part of the standard of care for individuals after their SCI because of the relative lack of research in this area. This study seeks to conduct a multisite pilot study to test whether a cognitive training program can improve processing speed abilities in individuals shortly after they experience their SCI, with the hopes that this early intervention will improve the trajectory of their overall health and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: game-like computerized activitiespre-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 |
| Placebo Control | Placebo comparator | Behavioral: game-like computerized activitiespre-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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old
- recent traumatic SCI (approximately 6 months post-injury)
Key exclusion criteria (2 listed)
- no other significant neurological, psychiatric or substance use history
- no significantly impairing visual disturbance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| game-like computerized activitiesgame-like computerized activities | Behavioural | Experimental |
| game-like computerized activitiesgame-like computerized activities | Behavioural | Placebo Control |
Primary outcome
Useful Field of View (UFOV)
Time frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
computerized processing speed task
Letter and Pattern Comparison (LPC)
Time frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
processing speed task, using both letter and pattern strings
Symbol Digit Modalities Test (SDMT)
Time frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
processing speed task, matching numbers to symbols using a key
1 secondary outcome
Spinal Cord Injury Quality of Life scales (SCI-QOL)
Time frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Weber, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing game-like computerized activities in people with Spinal Cord Injuries and Cognitive Dysfunction, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erica Weber, PhD (6176453678, eweber@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Useful Field of View (UFOV) (time frame: baseline to immediate post-treatment (week 13) and long-term follow-up (week 25)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.