Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: Placebo; memory exercise; Behavioral: Behavorial; memory exercise; Behavioral: Placebo speed training

• Registration Number: NCT03985540
• Lead Sponsor: Kessler Foundation

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 Timeline

• Study Start: 2016-11-16
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-13
• Primary Completion: 2022-10-30
• Study Completion: 2022-11-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo comparator memory	Placebo; memory exercise	Placebo controlled group will receive placebo memory retraining exercises administered on a lab top computer twice a week for 5 weeks.
memory experimental group	Behavorial; memory exercise	Experimental group will receive memory retraining exercises administered on a lab top computer twice a week for 5 weeks.
Processing speed placebo	Placebo speed training	Placebo controlled group will receive placebo processing speed training exercises administered on a lab top computer twice a week for 5 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States