Treating Cognitive Deficits in Spinal Cord Injury

NCT03037879 | Completed

• 1 other identifier: WEC-16-059
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Blood Pressure; Cerebral Blood Flow; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Systolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]

  Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)

• Diastolic Blood Pressure [Change from baseline at immediate follow up (post treatment) and long term follow-up (6months post treatment)]

  Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)

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

  Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)

Study Arms (4)

SPT

EXPERIMENTAL

Speed of Processing Training

Other: SPT

Control Group SPT

ACTIVE COMPARATOR

Control group to SPT treatment group

Other: SPT Control

mSMT

EXPERIMENTAL

Story Memory Technique

Other: mSMT

Control mSMT

ACTIVE COMPARATOR

Control group to mSMT treatment group

Other: mSMT Control

Interventions

SPT OTHER

Participants in the SPT group will receive 10 training sessions over 5 weeks.

SPT

SPT Control OTHER

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.

Control Group SPT

mSMT OTHER

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.

mSMT

mSMT Control OTHER

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.

Control mSMT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead
• Kessler Foundation: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jill M Wecht, Ed.D.

  James J. Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Scientist

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 31, 2017
• Study Start: April 13, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)