<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03037879</url>
  </required_header>
  <id_info>
    <org_study_id>WEC-16-059</org_study_id>
    <nct_id>NCT03037879</nct_id>
  </id_info>
  <brief_title>Treating Cognitive Deficits in Spinal Cord Injury</brief_title>
  <official_title>Treating Cognitive Deficits in Traumatic Spinal Cord Injury: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>James J. Peters Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kessler Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>James J. Peters Veterans Affairs Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple studies in the spinal cord injury (SCI) population have documented deficits in&#xD;
      learning and memory (LM) and processing speed (PS) that adversely impact daily life and the&#xD;
      ability to benefit from rehabilitation. The investigators have previously attributed the&#xD;
      cognitive deficits demonstrated in the SCI population to low blood pressure (BP) and cerebral&#xD;
      blood flow (CBF) and are currently conducting a study to determine the effect of a 30-day&#xD;
      elevation in BP (using midodrine hydrochloride - an alpha agonist) on CBF and cognitive&#xD;
      performance compared to placebo in hypotensive individuals with SCI. In addition, the&#xD;
      investigators believe that cognitive behavior therapy (CBT) may improve cognition independent&#xD;
      of changes in BP and CBF in individuals with SCI. The current randomized clinical trial (RCT)&#xD;
      will examine the efficacy of 2 treatment protocols shown to be effective in improving&#xD;
      cognitive performance in other neurologically impaired populations for use in persons with&#xD;
      SCI demonstrating (1) LM impairment and/or (2) PS impairment on objective measures of&#xD;
      cognitive functioning during a complete Neuropsychological assessment. Two methods of outcome&#xD;
      assessment will be used to examine treatment impact: (1) a traditional Neuropsychological&#xD;
      assessment (NP) and (2) an assessment of global functioning (AGF) composed of broader outcome&#xD;
      measures that examine the impact of the treatment on everyday life activities. In this way,&#xD;
      the investigators will be able to objectively evaluate the presence or absence of changes in&#xD;
      memory performance through a NP assessment, while also evaluating the impact of this&#xD;
      treatment protocol on everyday life through the AGF. While most studies evaluating the&#xD;
      efficacy of cognitive retraining usually employ a pre- and post-training evaluation, such&#xD;
      evaluations have been criticized for their lack of ecological validity (i.e., real world&#xD;
      generalizability). The present design allows the assessment of the efficacy of these&#xD;
      treatment techniques within an SCI population using traditional measures, as well as the&#xD;
      assessment of the impact that treatment has on everyday life. The investigators will&#xD;
      additionally evaluate the long-term efficacy by including a 6-month post-treatment follow-up.&#xD;
      Few studies examine long-term effects, but given the time, labor and expense involved, it is&#xD;
      critical to demonstrate long-term efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      104 individuals with SCI will be recruited for eligibility to participate in the study.&#xD;
      Participants will be randomly assigned to 4 groups (n=26 per group) story memory technique&#xD;
      (mSMT), mSMT control, speed of processing training (SPT) and SPT control.&#xD;
&#xD;
      The study involves 14 visits spread over 8 months. A screening visit, lasting approximately 1&#xD;
      hour. 3 testing sessions lasting 3-4 hours each (Baseline, Immediate and Long-term&#xD;
      follow-ups), and 10 intervention sessions that will last approximately 45 minutes each.&#xD;
&#xD;
      Screening: Prior to enrollment in the study protocol, all potential subjects will undergo&#xD;
      cognitive screening to determine eligibility for participation.&#xD;
&#xD;
      Baseline: After passing screening, subjects will be scheduled for the baseline evaluation&#xD;
      comprised of a cardiovascular/cerebrovascular assessment and cognitive evaluation.&#xD;
&#xD;
      Intervention: Subjects will undergo 10 sessions of training in one of the 4 randomized&#xD;
      groups.&#xD;
&#xD;
      Immediate Follow-up Assessment: Subjects will undergo a repeat of the baseline assessments&#xD;
      upon completion of the intervention protocol to document changes in PS, LM, BP and CBF&#xD;
      following treatment.&#xD;
&#xD;
      Long-Term Follow-up: Subjects will be asked to return to the laboratory 6 months following&#xD;
      the intervention for evaluation of the maintenance of the treatment effect over time.&#xD;
      Baseline and Immediate follow-up measures of PS, LM, BP and CBF will be documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 13, 2017</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neuropsychological Tests [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]</measure>
    <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)</time_frame>
    <description>NP testing will be conducted to document levels of cognitive performance. NP assessment will identify persons who qualifies for study participation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]</measure>
    <time_frame>Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]</measure>
    <time_frame>Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral Blood Flow Velocity [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]</measure>
    <time_frame>Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Spinal Cord Injury</condition>
  <condition>Blood Pressure</condition>
  <condition>Cerebral Blood Flow</condition>
  <condition>Cognitive Function</condition>
  <arm_group>
    <arm_group_label>SPT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Speed of Processing Training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group SPT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group to SPT treatment group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mSMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Story Memory Technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control mSMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group to mSMT treatment group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SPT</intervention_name>
    <description>Participants in the SPT group will receive 10 training sessions over 5 weeks.</description>
    <arm_group_label>SPT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SPT Control</intervention_name>
    <description>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.</description>
    <arm_group_label>Control Group SPT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mSMT</intervention_name>
    <description>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.</description>
    <arm_group_label>mSMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mSMT Control</intervention_name>
    <description>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.</description>
    <arm_group_label>Control mSMT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary language is English;&#xD;
&#xD;
          -  Level of Spinal Cord Injury between C1 and T12;&#xD;
&#xD;
          -  Non-ambulatory (wheelchair dependent);&#xD;
&#xD;
          -  American Spinal Injury Association (AISA) grade A, B or C;&#xD;
&#xD;
          -  Spinal Cord Injury occurred more than 1 year ago.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute illness or infection.&#xD;
&#xD;
          -  Documented history of:&#xD;
&#xD;
          -  Controlled or uncontrolled Hypertension or Diabetes Mellitus;&#xD;
&#xD;
          -  Stroke;&#xD;
&#xD;
          -  Multiple sclerosis &amp; Parkinson's disease;&#xD;
&#xD;
          -  Psychiatric disorders (post-traumatic stress disorder, schizophrenia; bipolar&#xD;
             disorder);&#xD;
&#xD;
          -  Pre-screen MoCA score of &lt; 22 (to rule out dementia);&#xD;
&#xD;
          -  Vision impaired - more than 20/60 in worst eye (with prescription eyewear).&#xD;
&#xD;
          -  Currently prescribed steroids, benzodiazepines, or neuroleptics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jill M Wecht, Ed.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>James J. Peters VA Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kessler Foundation</name>
      <address>
        <city>West Orange</city>
        <state>New Jersey</state>
        <zip>07052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>James J. Peters Veterans Affairs Medical Center</investigator_affiliation>
    <investigator_full_name>Jill M. Wecht, Ed.D.</investigator_full_name>
    <investigator_title>Research Health Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Cognition Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037879
org study id: WEC-16-059
nct id: NCT03037879
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: 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)
description: NP testing will be conducted to document levels of cognitive performance. NP assessment will identify persons who qualifies for study participation.
measure: 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)
description: 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).
measure: 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)
description: 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).
measure: 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)
description: 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).
arm group label: SPT
arm group type: Experimental
description: Speed of Processing Training
arm group label: Control Group SPT
arm group type: Active Comparator
description: Control group to SPT treatment group
arm group label: mSMT
arm group type: Experimental
description: Story Memory Technique
arm group label: Control mSMT
arm group type: Active Comparator
description: Control group to mSMT treatment group
intervention type: Other
intervention name: SPT
description: Participants in the SPT group will receive 10 training sessions over 5 weeks.
arm group label: SPT
intervention type: Other
intervention name: SPT Control
description: 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.
arm group label: Control Group SPT
intervention type: Other
intervention name: mSMT
description: 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.
arm group label: mSMT
intervention type: Other
intervention name: mSMT Control
description: 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.
arm group label: Control mSMT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jill M Wecht, Ed.D.
role: Principal Investigator
affiliation: James J. Peters VA Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: James J. Peters Veterans Affairs Medical Center
investigator full name: Jill M. Wecht, Ed.D.
investigator title: Research Health Scientist
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
mesh term: Cognition Disorders
mesh term: Cognitive Dysfunction
sharing ipd: Undecided