Blood Pressure Clinical Trial
Official title:
Treating Cognitive Deficits in Traumatic Spinal Cord Injury: A Randomized Clinical Trial
Verified date | June 2023 |
Source | James J. Peters Veterans Affairs Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
James J. Peters Veterans Affairs Medical Center | Kessler Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Screening (before baseline measures), Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) | |
Secondary | 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). | Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) | |
Secondary | 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). | Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) | |
Secondary | 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). | Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up) |
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