Back to results

Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

Primary Purpose

Spinal Cord Injuries

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavorial; memory exercise

Placebo; memory exercise

Behavioral: speed exercises

Placebo speed training

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

memory experimental group

Placebo comparator memory

Processing speed

Processing speed placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

California Verbal Learning Test

California Verbal Learning TestPerformance on a memory test using the

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT03985540

First Posted

August 15, 2017

Last Updated

January 16, 2023

Sponsor

Kessler Foundation

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research

1. Study Identification

Unique Protocol Identification Number

NCT03985540

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

November 16, 2016 (Actual)

Primary Completion Date

October 30, 2022 (Actual)

Study Completion Date

November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kessler Foundation

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

memory experimental group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo comparator memory

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Processing speed

Arm Type

Experimental

Arm Description

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

Arm Title

Processing speed placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Behavorial; memory exercise

Intervention Description

Memory training twice a week for 5 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Placebo; memory exercise

Intervention Description

Placebo Memory training twice a week for 5 weeks

Intervention Type

Behavioral

Intervention Name(s)

Behavioral: speed exercises

Intervention Description

Speed training twice a week for 5 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Placebo speed training

Intervention Description

Placebo Speed training twice a week for 5 weeks.

Primary Outcome Measure Information:

Title

California Verbal Learning Test

Description

California Verbal Learning TestPerformance on a memory test using the

Time Frame

Assessments will look at change over 6 weeks of treatment and 3 months after completion

Secondary Outcome Measure Information:

Title

SCI Quality of Life Scale

Description

Time Frame

Assessments will look at change over 6 weeks of treatment and 3 months after completion

Other Pre-specified Outcome Measures:

Title

Symbol-Digit Modalities Test (oral form)

Description

Performance on processing speed test, Symbol-Digit Modalities Test (oral form)

Time Frame

Assessments will look at change over 6 weeks of treatment and 3 months after completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Green, PhD

Organizational Affiliation

Kessler Foundation

Official's Role

Study Chair

Facility Information:

Facility Name

Kessler Foundation

City

West Orange

State/Province

New Jersey

ZIP/Postal Code

07052

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

We'll reach out to this number within 24 hrs