Treating Cognitive Deficits in Spinal Cord Injury
Condition: Spinal Cord Injury; Blood Pressure; Cerebral Blood Flow; Cognitive Function
MeSH terms: Spinal Cord Injuries; Wounds and Injuries; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

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.
    

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.
    

Intervention name(s): SPT; SPT Control; mSMT; mSMT Control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants in the SPT group will receive 10 training sessions over 5 weeks.; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment