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Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

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ClinicalTrials.gov Identifier: NCT03985540
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Nancy Chiaravalloti, 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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Behavorial; memory exercise Behavioral: Placebo; memory exercise Behavioral: Behavioral: speed exercises Behavioral: Placebo speed training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial
Actual Study Start Date : November 16, 2016
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : November 14, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. California Verbal Learning Test [ Time Frame: 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 :
  1. SCI Quality of Life Scale [ Time Frame: 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).


Other Outcome Measures:
  1. Symbol-Digit Modalities Test (oral form) [ Time Frame: Assessments will look at change over 6 weeks of treatment and 3 months after completion ]
    Performance on processing speed test, Symbol-Digit Modalities Test (oral form)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985540


Contacts
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Contact: Belinda L Washington, BA 973-324-8446 bwashington@kesslerfoundation.org
Contact: Nancy B Moore, MA 973-324-8450 nbmoore@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Belinda L Washington, BA    973-324-8446    bwashington@kesslerfoundation.org   
Contact: Nancy B Moore, MA    973-324-8450    nbmoore@kesslerfoundation.org   
Principal Investigator: Nancy Chiaravalloti, PhD         
Sponsors and Collaborators
Kessler Foundation
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
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Study Chair: Richard Green, PhD Kessler Foundation

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Responsible Party: Nancy Chiaravalloti, Director NNL & TBI, Kessler Foundation
ClinicalTrials.gov Identifier: NCT03985540     History of Changes
Other Study ID Numbers: R-947-16
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Cognition Disorders
Cognitive Dysfunction
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurocognitive Disorders
Mental Disorders
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors