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CompletedNCT03985540Updated Jan 18, 2023

Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

An interventional study of Behavorial; memory exercise and Placebo; memory exercise in Spinal Cord Injuries, sponsored by Kessler Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2016, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

The purpose of this research study is to investigate the effectiveness of a memory retraining program and a processing speed program in a spinal cord injured (SCI) population. The study is designed to research how well different types of techniques can help people with SCI improve in areas where they might have difficulties such as memory or processing speed, (time it takes to process information provided).

Read the detailed description

The objectives of the currently proposed randomized clinical trial are to (1) apply a treatment protocol for Processing Speed and Learning and memory impairments, well-validated in other neurological populations, to individuals with SCI with objectively observable deficits in these areas and document efficacy on standard neuropsychological testing; (2) assess the effectiveness of the interventions in persons with SCI utilizing global measures of everyday life; (3) evaluate the long-term benefit of treatment. Prior to enrollment in the study protocol, all potential subjects will undergo a 2-part screening: (1) an initial screening examination via telephone during which basic information will be gathered and (2) a detailed, in-person screening that will be completed on if the subject passes the initial screen. Individuals must meet full screening criteria to be eligible for participation.

02

Conditions studied

03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 104 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • I am between the ages of 18 and 75 years old.
  • I have a spinal cord injury with the level of injury between C1-T12.
  • I am non-ambulatory (I use a wheelchair as my primary means of getting around).
  • I have an AIS grade of A, B or C as determined by study staff examination.
  • My injury occurred at least 1 year ago.
  • My primary language is English.

Exclusion criteria

Exclusion Criteria:

  • I have a current illness or infection. My enrollment in this study can be delayed until my current illness or infection is successfully treated.
  • I have any neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.).
  • I have a diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
  • I have a history of Hypertension or Diabetes Mellitus (due to its impact on brain function).
  • My vision is impaired- more than 20/60 in worst eye (with prescription eyewear).
  • I have been taking steroids, benzodiazepines, or certain neuroleptics within past month, the study doctor will review my medications with me.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    memory experimental group

    Experimental group will receive memory retraining exercises administered on a lab top computer twice a week for 5 weeks.

    Behavioral: Behavorial; memory exercise

  • Placebo comparator
    Placebo comparator memory

    Placebo controlled group will receive placebo memory retraining exercises administered on a lab top computer twice a week for 5 weeks.

    Behavioral: Placebo; memory exercise

  • Experimental
    Processing speed

    Processing speed group will receive processing speed training exercises administered on a lab top computer twice a week for 5 weeks.

    Behavioral: Behavioral: speed exercises

  • Placebo comparator
    Processing speed placebo

    Placebo controlled group will receive placebo processing speed training exercises administered on a lab top computer twice a week for 5 weeks.

    Behavioral: Placebo speed training

Interventions

  • BehavioralBehavorial; memory exercise

    Memory training twice a week for 5 weeks.

  • BehavioralPlacebo; memory exercise

    Placebo Memory training twice a week for 5 weeks

  • BehavioralBehavioral: speed exercises

    Speed training twice a week for 5 weeks.

  • BehavioralPlacebo speed training

    Placebo Speed training twice a week for 5 weeks.

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What researchers measure

Primary outcomes

  1. California Verbal Learning Test

    California Verbal Learning TestPerformance on a memory test using the

    Time frame: Assessments will look at change over 6 weeks of treatment and 3 months after completion

Secondary outcomes

  1. SCI Quality of Life Scale

    Reports on emotional functioning, memory functioning and quality of life using the SCI Quality of Life Scale, which measures all of these constructs. DVs will be the depression subscale (range: 0-40; lower score is better) and cognitive subscale (range:0-40; higher score is better).

    Time frame: Assessments will look at change over 6 weeks of treatment and 3 months after completion

Other outcomes

  1. Symbol-Digit Modalities Test (oral form)

    Performance on processing speed test, Symbol-Digit Modalities Test (oral form)

    Time frame: Assessments will look at change over 6 weeks of treatment and 3 months after completion

07

Study locations

1 site
  • Kessler Foundation
    West Orange, New Jersey 07052, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03985540
Lead sponsor
Kessler Foundation
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
Responsible party
Nancy Chiaravalloti (Director NNL & TBI, Kessler Foundation) — Principal investigator
First posted
Jun 13, 2019
Start date
Nov 16, 2016
Primary completion
Oct 30, 2022
Completion
Nov 14, 2022
Last update
Jan 18, 2023

Study contacts

Richard Green, PhD
study chair · Kessler Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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