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NCT03037879 · ClinicalTrials.gov registry record · NA
Treating Cognitive Deficits in Spinal Cord Injury
A NA study of Blood Pressure and Spinal Cord Injury, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03037879 is a NA study of Blood Pressure and Spinal Cord Injury that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 10 participants, below the 287-participant average among 101 other Blood Pressure trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03037879, a NA study of Blood Pressure and Spinal Cord Injury, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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 wi
Conditions Studied
Interventions
- OTHER SPT
- OTHER SPT Control
- OTHER mSMT
- OTHER mSMT Control
Study Locations (1)
New Jersey
- Kessler Foundation - West Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-04-13 |
| Est. Completion | 2021-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03037879
The ClinicalTrials.gov registry entry for NCT03037879 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 287-participant average among 101 other Blood Pressure trials with a reported enrollment target (97% lower). The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Blood Pressure appearing as the primary indexed condition, and to 4 interventions - of which SPT is the first listed.
NCT03037879 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT03037879 about?
NCT03037879 is a clinical study titled "Treating Cognitive Deficits in Spinal Cord Injury". 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...
What is the current status of trial NCT03037879?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2017-04-13. Estimated completion is 2021-09-30.
What conditions does trial NCT03037879 study?
This clinical trial studies the following conditions: Blood Pressure, Spinal Cord Injury, Cognitive Function, Cerebral Blood Flow.
What interventions are being tested in trial NCT03037879?
The interventions under investigation include: SPT (OTHER), SPT Control (OTHER), mSMT (OTHER), mSMT Control (OTHER).
Who is sponsoring clinical trial NCT03037879?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03037879 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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