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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| memory experimental group | Experimental | Experimental group will receive memory retraining exercises administered on a lab top computer twice a week for 5 weeks. |
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| Placebo comparator memory | Placebo Comparator | Placebo controlled group will receive placebo memory retraining exercises administered on a lab top computer twice a week for 5 weeks. |
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| Processing speed | Experimental | Processing speed group will receive processing speed training exercises administered on a lab top computer twice a week for 5 weeks. |
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| Processing speed placebo | Placebo Comparator | Placebo controlled group will receive placebo processing speed training exercises administered on a lab top computer twice a week for 5 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavorial; memory exercise | Behavioral | Memory training twice a week for 5 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| California Verbal Learning Test | California Verbal Learning TestPerformance on a memory test using the | Assessments will look at change over 6 weeks of treatment and 3 months after completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Assessments will look at change over 6 weeks of treatment and 3 months after completion |
| Measure | Description | Time Frame |
|---|---|---|
| Symbol-Digit Modalities Test (oral form) | Performance on processing speed test, Symbol-Digit Modalities Test (oral form) | Assessments will look at change over 6 weeks of treatment and 3 months after completion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Green, PhD | Kessler Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | West Orange | New Jersey | 07052 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Placebo; memory exercise | Behavioral | Placebo Memory training twice a week for 5 weeks |
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| Behavioral: speed exercises | Behavioral | Speed training twice a week for 5 weeks. |
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| Placebo speed training | Behavioral | Placebo Speed training twice a week for 5 weeks. |
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| D014947 | Wounds and Injuries |