Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

NCT ID: NCT03985540

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-16
• Study Completion Date: 2022-11-14

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

memory experimental group

Experimental group will receive memory retraining exercises administered on a lab top computer twice a week for 5 weeks.

Group Type: EXPERIMENTAL

Behavorial; memory exercise

Intervention Type: BEHAVIORAL

Memory training twice a week for 5 weeks.

Placebo comparator memory

Placebo controlled group will receive placebo memory retraining exercises administered on a lab top computer twice a week for 5 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo; memory exercise

Intervention Type: BEHAVIORAL

Placebo Memory training twice a week for 5 weeks

Processing speed

Processing speed group will receive processing speed training exercises administered on a lab top computer twice a week for 5 weeks.

Group Type: EXPERIMENTAL

Behavioral: speed exercises

Intervention Type: BEHAVIORAL

Speed training twice a week for 5 weeks.

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.

Group Type: PLACEBO_COMPARATOR

Placebo speed training

Intervention Type: BEHAVIORAL

Placebo Speed training twice a week for 5 weeks.

Interventions

Behavorial; memory exercise

Memory training twice a week for 5 weeks.

Intervention Type: BEHAVIORAL

Placebo; memory exercise

Placebo Memory training twice a week for 5 weeks

Intervention Type: BEHAVIORAL

Behavioral: speed exercises

Speed training twice a week for 5 weeks.

Intervention Type: BEHAVIORAL

Placebo speed training

Placebo Speed training twice a week for 5 weeks.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Nancy Chiaravalloti

Director NNL & TBI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Green, PhD

Role: STUDY_CHAIR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Other Identifiers

R-947-16

Identifier Type: -

Identifier Source: org_study_id