Spinal Cord Injuries
Conditions
Brief 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).
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.
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.
Sponsors
National Institute on Disability, Independent Living, and Rehabilitation Research
Kessler Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| California Verbal Learning Test | 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
| Measure | Time frame | Description |
|---|---|---|
| SCI Quality of Life Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Symbol-Digit Modalities Test (oral form) | 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) |
Countries
United States
Outcome results
None listed