search
Back to results

Treating Cognitive Deficits in Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Blood Pressure, Cerebral Blood Flow

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPT
SPT Control
mSMT
mSMT Control
Sponsored by
James J. Peters Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

SPT

Control Group SPT

mSMT

Control mSMT

Arm Description

Speed of Processing Training

Control group to SPT treatment group

Story Memory Technique

Control group to mSMT treatment group

Outcomes

Primary Outcome Measures

Neuropsychological Tests [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]
NP testing will be conducted to document levels of cognitive performance. NP assessment will identify persons who qualifies for study participation.

Secondary Outcome Measures

Systolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]
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).
Diastolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]
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).
Cerebral Blood Flow Velocity [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]
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).

Full Information

First Posted
January 25, 2017
Last Updated
June 23, 2023
Sponsor
James J. Peters Veterans Affairs Medical Center
Collaborators
Kessler Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03037879
Brief Title
Treating Cognitive Deficits in Spinal Cord Injury
Official Title
Treating Cognitive Deficits in Traumatic Spinal Cord Injury: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
James J. Peters Veterans Affairs Medical Center
Collaborators
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Blood Pressure, Cerebral Blood Flow, Cognitive Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPT
Arm Type
Experimental
Arm Description
Speed of Processing Training
Arm Title
Control Group SPT
Arm Type
Active Comparator
Arm Description
Control group to SPT treatment group
Arm Title
mSMT
Arm Type
Experimental
Arm Description
Story Memory Technique
Arm Title
Control mSMT
Arm Type
Active Comparator
Arm Description
Control group to mSMT treatment group
Intervention Type
Other
Intervention Name(s)
SPT
Intervention Description
Participants in the SPT group will receive 10 training sessions over 5 weeks.
Intervention Type
Other
Intervention Name(s)
SPT Control
Intervention 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.
Intervention Type
Other
Intervention Name(s)
mSMT
Intervention 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.
Intervention Type
Other
Intervention Name(s)
mSMT Control
Intervention 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.
Primary Outcome Measure Information:
Title
Neuropsychological Tests [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]
Description
NP testing will be conducted to document levels of cognitive performance. NP assessment will identify persons who qualifies for study participation.
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)
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]
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).
Time Frame
Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)
Title
Diastolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]
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).
Time Frame
Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)
Title
Cerebral Blood Flow Velocity [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]
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).
Time Frame
Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill M Wecht, Ed.D.
Organizational Affiliation
James J. Peters VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Treating Cognitive Deficits in Spinal Cord Injury

We'll reach out to this number within 24 hrs