Skip to main content
OpenTrials
Completed

NCT Number: NCT03985540

Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Behavorial; memory exercise

Behavioral

Memory training twice a week for 5 weeks.

Placebo; memory exercise

Behavioral

Placebo Memory training twice a week for 5 weeks

Behavioral: speed exercises

Behavioral

Speed training twice a week for 5 weeks.

Placebo speed training

Behavioral

Placebo Speed training twice a week for 5 weeks.

Primary outcomes

  1. California Verbal Learning Test

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

    California Verbal Learning TestPerformance on a memory test using the

Secondary outcomes

  1. SCI Quality of Life Scale

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

    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).

Other outcomes

  1. Symbol-Digit Modalities Test (oral form)

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

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

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2019
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.