Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Memory training twice a week for 5 weeks.
|
| 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
Placebo Memory training twice a week for 5 weeks
|
| 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
Speed training twice a week for 5 weeks.
|
| 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
Placebo Speed training twice a week for 5 weeks.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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I am between the ages of 18 and 75 years old.
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I have a spinal cord injury with the level of injury between C1-T12.
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I am non-ambulatory (I use a wheelchair as my primary means of getting around).
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I have an AIS grade of A, B or C as determined by study staff examination.
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My injury occurred at least 1 year ago.
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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.
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I have any neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.).
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I have a diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
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I have a history of Hypertension or Diabetes Mellitus (due to its impact on brain function).
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My vision is impaired- more than 20/60 in worst eye (with prescription eyewear).
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I have been taking steroids, benzodiazepines, or certain neuroleptics within past month, the study doctor will review my medications with me.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kessler Foundation | West Orange | New Jersey | United States | 07052 |
Sponsors and Collaborators
- Kessler Foundation
- National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
- Study Chair: Richard Green, PhD, Kessler Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R-947-16