Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

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

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).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Behavioral: Behavorial; memory exercise; Behavioral: Placebo; memory exercise; Behavioral: Behavioral: speed exercises; Behavioral: Placebo speed training

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 Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: memory experimental group; Experimental group will receive memory retraining exercises administered on a lab top computer twice a week for 5 weeks.	Behavioral: Behavorial; memory exercise; Memory training twice a week for 5 weeks.
Placebo Comparator: Placebo comparator memory; Placebo controlled group will receive placebo memory retraining exercises administered on a lab top computer twice a week for 5 weeks.	Behavioral: Placebo; memory exercise; Placebo Memory training twice a week for 5 weeks
Experimental: Processing speed; Processing speed group will receive processing speed training exercises administered on a lab top computer twice a week for 5 weeks.	Behavioral: Behavioral: speed exercises; Speed training twice a week for 5 weeks.
Placebo Comparator: 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.	Behavioral: Placebo speed training; Placebo Speed training twice a week for 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Study Chair: Richard Green, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2016
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Cognitive Dysfunction; Cognition Disorders; Spinal Cord Injuries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: R-947-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No