Clinical trial NCT03985540: Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)
Official title: Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2019-06-13
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: California Verbal Learning Test
timeFrame: Assessments will look at change over 6 weeks of treatment and 3 months after completion
Secondary outcomes:
measure: SCI Quality of Life Scale
timeFrame: Assessments will look at change over 6 weeks of treatment and 3 months after completion
Other outcomes:
measure: Symbol-Digit Modalities Test (oral form)
timeFrame: Assessments will look at change over 6 weeks of treatment and 3 months after completion
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Richard Green, PhD
role: STUDY_CHAIR
References: