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SPT for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord Injury+3 MoreSPT - Other
Eligibility
18 - 75
All Sexes
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Study Summary

This trial is examining the efficacy of two treatment protocols for improving cognitive performance in people with spinal cord injuries, compared to placebo. The treatment protocols involve midodrine hydrochloride (an alpha agonist) and cognitive behavior therapy. The study will use neuropsychological and global functioning assessments to evaluate the impact of the treatment on memory performance and everyday life activities, respectively. The investigators will also evaluate the long-term efficacy of the treatment by including a 6-month post-treatment follow-up.

Eligible Conditions
  • Cerebral Blood Flow
  • High Blood Pressure
  • Cognitive Functioning
  • Spinal Cord Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Screening (before baseline measures), Baseline, Immediate Follow-up (about 2 months after baseline), Long-term Follow-up (6 months after immediate follow-up)

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

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Naltrexone Hydrochloride
1
Pembrolizumab
1
Temozolomide

Trial Design

4 Treatment Groups

Control Group SPT
1 of 4
Control mSMT
1 of 4
SPT
1 of 4
mSMT
1 of 4

Active Control

Experimental Treatment

104 Total Participants · 4 Treatment Groups

Primary Treatment: SPT · No Placebo Group · N/A

SPT
Other
Experimental Group · 1 Intervention: SPT · Intervention Types: Other
mSMT
Other
Experimental Group · 1 Intervention: mSMT · Intervention Types: Other
Control Group SPT
Other
ActiveComparator Group · 1 Intervention: SPT Control · Intervention Types: Other
Control mSMT
Other
ActiveComparator Group · 1 Intervention: mSMT Control · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: screening (before baseline measures), baseline, immediate follow-up (about 2 months after baseline), long-term follow-up (6 months after immediate follow-up)

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor
53 Previous Clinical Trials
2,927 Total Patients Enrolled
Kessler FoundationOTHER
155 Previous Clinical Trials
10,211 Total Patients Enrolled
Jill M Wecht, Ed.D.Principal InvestigatorJames J. Peters VA Medical Center
3 Previous Clinical Trials
221 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 5 Total Inclusion Criteria

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References

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