Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

Spinal Cord Injuries Clinical Trial

Official title:

Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985540
• Other study ID #: R-947-16
• Status: Completed
• Phase: N/A
• Start date: November 16, 2016
• Est. completion date: November 14, 2022

Study information

• Verified date: January 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 14, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Behavorial; memory exercise
Memory training twice a week for 5 weeks.
• Placebo; memory exercise
Placebo Memory training twice a week for 5 weeks
• Behavioral: speed exercises
Speed training twice a week for 5 weeks.
• Placebo speed training
Placebo Speed training twice a week for 5 weeks.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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