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出境医 / 临床实验 / Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)
Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)
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 |
|---|---|---|
| Spinal Cord Injuries | Behavioral: Behavorial; memory exercise Behavioral: Placebo; memory exercise Behavioral: Behavioral: speed exercises Behavioral: Placebo speed training | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 104 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial |
| Actual Study Start Date : | November 16, 2016 |
| Estimated Primary Completion Date : | October 30, 2021 |
| Estimated Study Completion Date : | November 14, 2021 |
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 [ 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 Outcome Measures :
- 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 Outcome Measures:
- 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)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Contacts
| Contact: Belinda L Washington, BA | 973-324-8446 | bwashington@kesslerfoundation.org | |
| Contact: Nancy B Moore, MA | 973-324-8450 | nbmoore@kesslerfoundation.org |
Locations
| United States, New Jersey | |
| Kessler Foundation | Recruiting |
| West Orange, New Jersey, United States, 07052 | |
| Contact: Belinda L Washington, BA 973-324-8446 bwashington@kesslerfoundation.org | |
| Contact: Nancy B Moore, MA 973-324-8450 nbmoore@kesslerfoundation.org | |
| Principal Investigator: Nancy Chiaravalloti, PhD | |
Sponsors and Collaborators
Kessler Foundation
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
| Study Chair: | Richard Green, PhD | Kessler Foundation |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | August 15, 2017 | ||||||||
| First Posted Date ICMJE | June 13, 2019 | ||||||||
| Last Update Posted Date | February 18, 2021 | ||||||||
| Actual Study Start Date ICMJE | November 16, 2016 | ||||||||
| Estimated Primary Completion Date | October 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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).
|
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| Original Secondary Outcome Measures ICMJE |
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
|
||||||||
| Current Other Pre-specified Outcome Measures |
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)
|
||||||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI) | ||||||||
| Official Title ICMJE | Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Spinal Cord Injuries | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
104 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | November 14, 2021 | ||||||||
| Estimated Primary Completion Date | October 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03985540 | ||||||||
| Other Study ID Numbers ICMJE | R-947-16 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Nancy Chiaravalloti, Kessler Foundation | ||||||||
| Study Sponsor ICMJE | Kessler Foundation | ||||||||
| Collaborators ICMJE | National Institute on Disability, Independent Living, and Rehabilitation Research | ||||||||
| Investigators ICMJE |
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| PRS Account | Kessler Foundation | ||||||||
| Verification Date | February 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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