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Treating Cognitive Deficits in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03037879
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

Brief Summary:
Multiple studies in the spinal cord injury (SCI) population have documented deficits in learning and memory (LM) and processing speed (PS) that adversely impact daily life and the ability to benefit from rehabilitation. The investigators have previously attributed the cognitive deficits demonstrated in the SCI population to low blood pressure (BP) and cerebral blood flow (CBF) and are currently conducting a study to determine the effect of a 30-day elevation in BP (using midodrine hydrochloride - an alpha agonist) on CBF and cognitive performance compared to placebo in hypotensive individuals with SCI. In addition, the investigators believe that cognitive behavior therapy (CBT) may improve cognition independent of changes in BP and CBF in individuals with SCI. The current randomized clinical trial (RCT) will examine the efficacy of 2 treatment protocols shown to be effective in improving cognitive performance in other neurologically impaired populations for use in persons with SCI demonstrating (1) LM impairment and/or (2) PS impairment on objective measures of cognitive functioning during a complete Neuropsychological assessment. Two methods of outcome assessment will be used to examine treatment impact: (1) a traditional Neuropsychological assessment (NP) and (2) an assessment of global functioning (AGF) composed of broader outcome measures that examine the impact of the treatment on everyday life activities. In this way, the investigators will be able to objectively evaluate the presence or absence of changes in memory performance through a NP assessment, while also evaluating the impact of this treatment protocol on everyday life through the AGF. While most studies evaluating the efficacy of cognitive retraining usually employ a pre- and post-training evaluation, such evaluations have been criticized for their lack of ecological validity (i.e., real world generalizability). The present design allows the assessment of the efficacy of these treatment techniques within an SCI population using traditional measures, as well as the assessment of the impact that treatment has on everyday life. The investigators will additionally evaluate the long-term efficacy by including a 6-month post-treatment follow-up. Few studies examine long-term effects, but given the time, labor and expense involved, it is critical to demonstrate long-term efficacy.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Blood Pressure Cerebral Blood Flow Cognitive Function Other: SPT Other: SPT Control Other: mSMT Other: mSMT Control Not Applicable

Detailed Description:

104 individuals with SCI will be recruited for eligibility to participate in the study. Participants will be randomly assigned to 4 groups (n=26 per group) story memory technique (mSMT), mSMT control, speed of processing training (SPT) and SPT control.

The study involves 14 visits spread over 8 months. A screening visit, lasting approximately 1 hour. 3 testing sessions lasting 3-4 hours each (Baseline, Immediate and Long-term follow-ups), and 10 intervention sessions that will last approximately 45 minutes each.

Screening: Prior to enrollment in the study protocol, all potential subjects will undergo cognitive screening to determine eligibility for participation.

Baseline: After passing screening, subjects will be scheduled for the baseline evaluation comprised of a cardiovascular/cerebrovascular assessment and cognitive evaluation.

Intervention: Subjects will undergo 10 sessions of training in one of the 4 randomized groups.

Immediate Follow-up Assessment: Subjects will undergo a repeat of the baseline assessments upon completion of the intervention protocol to document changes in PS, LM, BP and CBF following treatment.

Long-Term Follow-up: Subjects will be asked to return to the laboratory 6 months following the intervention for evaluation of the maintenance of the treatment effect over time. Baseline and Immediate follow-up measures of PS, LM, BP and CBF will be documented.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Cognitive Deficits in Traumatic Spinal Cord Injury: A Randomized Clinical Trial
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SPT
Speed of Processing Training
Other: SPT
Participants in the SPT group will receive 10 training sessions over 5 weeks.

Active Comparator: Control Group SPT
Control group to SPT treatment group
Other: SPT Control
Participants in the SPT control group will receive 10 computer-based control sessions over a five-week period during which they will engage in computer-based training. However, they will not be exposed to the training materials central to the SPT.

Experimental: mSMT
Story Memory Technique
Other: mSMT
Participants in the mSMT group will meet with the trainer twice per week for five weeks. Sessions last 45-60 minutes each and are spread over 5 weeks.

Active Comparator: Control mSMT
Control group to mSMT treatment group
Other: mSMT Control
Participants in the mSMT control group will meet with the therapist at the same frequency and for the same duration as those in the mSMT experimental group. However, subjects will not be exposed to the training materials central to the mSMT.




Primary Outcome Measures :
  1. Neuropsychological Tests [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)] [ Time Frame: Screening (before baseline measures), Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) ]
    NP testing will be conducted to document levels of cognitive performance. NP assessment will identify persons who qualifies for study participation.


Secondary Outcome Measures :
  1. Systolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)] [ Time Frame: Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) ]
    Brachial BP will be measured by a trained technician using a standard adult BP cuff (GE Healthcare Information Technologies, Milwaukee, WI) at 60-second intervals. Beat-to-beat finger arteriolar BP will be monitored continuously from the left middle or ring finger using photoplethysmography (FMS: Finometer, model 2; Amsterdam, Netherlands).

  2. Diastolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)] [ Time Frame: Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) ]
    Brachial BP will be measured by a trained technician using a standard adult BP cuff (GE Healthcare Information Technologies, Milwaukee, WI) at 60-second intervals. Beat-to-beat finger arteriolar BP will be monitored continuously from the left middle or ring finger using photoplethysmography (FMS: Finometer, model 2; Amsterdam, Netherlands).

  3. Cerebral Blood Flow Velocity [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)] [ Time Frame: Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) ]
    A transcranial Doppler (TCD) ultrasound probe will be used to locate the left middle cerebral artery (MCA). Once the MCA is located a head harness will be used to secure probe placement for assessment of resting cerebral blood flow velocity (CBFv).



Information from the National Library of Medicine

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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:

  • Primary language is English;
  • Level of Spinal Cord Injury between C1 and T12;
  • Non-ambulatory (wheelchair dependent);
  • American Spinal Injury Association (AISA) grade A, B or C;
  • Spinal Cord Injury occurred more than 1 year ago.

Exclusion Criteria:

  • Acute illness or infection.
  • Documented history of:
  • Controlled or uncontrolled Hypertension or Diabetes Mellitus;
  • Stroke;
  • Multiple sclerosis & Parkinson's disease;
  • Psychiatric disorders (post-traumatic stress disorder, schizophrenia; bipolar disorder);
  • Pre-screen MoCA score of < 22 (to rule out dementia);
  • Vision impaired - more than 20/60 in worst eye (with prescription eyewear).
  • Currently prescribed steroids, benzodiazepines, or neuroleptics.

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): NCT03037879


Contacts
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Contact: Alexander T Lombard, M.S. 973-324-3588 alombard@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Alexander T Lombard, M.S.    973-324-3588    alombard@kesslerfoundation.org   
Contact: Caitlyn G Katzelnick, M.S.    973-324-3588    ckatzelnick@kesslerfoundation.org   
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Kessler Foundation
Investigators
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Principal Investigator: Jill M Wecht, Ed.D. James J. Peters VA Medical Center

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Responsible Party: Jill M. Wecht, Ed.D., Research Health Scientist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03037879     History of Changes
Other Study ID Numbers: WEC-16-059
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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