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Functional Electrical Stimulation for Orthostatic Hypotension

N/A

Waitlist Available

Led By Karen Hux, Ph.D.

Research Sponsored by Quality Living, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

SCI at the level of C5 or higher

Be older than 18 years old

Must not have

Any person who has a legally authorized representative responsible for making healthcare decisions because of compromised cognitive or communication status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured every three minutes throughout the time a participant is positioned on the tilt table

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn more about how to effectively treat orthostatic hypotension in people with spinal cord injuries.

Who is the study for?

This trial is for adults with cervical spinal cord injury at C5 level or higher, living at Quality Living Inc., who experience a significant drop in blood pressure when standing up. They must understand English well enough to consent and can't have someone else making healthcare decisions for them or any health condition that makes FES unsafe.

What is being tested?

The study tests if functional electrical stimulation (FES) helps control low blood pressure due to spinal cord injury when standing. It compares the effects of placing FES electrodes on different body parts—calves, quads and abdominals, both combined—to no FES during tilt table sessions.

What are the potential side effects?

While not explicitly stated, potential side effects of FES may include skin irritation where electrodes are placed, muscle fatigue, discomfort from the electrical stimulation, and unintended muscle contractions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My spinal cord injury is at C5 or above.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have someone legally appointed to make healthcare decisions for me due to my cognitive or communication issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured over the course of each one hour tilt table session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured over the course of each one hour tilt table session

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured over the course of each one hour tilt table session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in blood pressure from initial reading at start of each tilt table session

Change in tilt table angle from 0 degrees to maximum tolerated during session

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

All participants will receive intervention in four conditions: (a) no FES, (b) calves only FES, (c) quads and abdominals only FES, and (d) calves, quads, and abdominals FES. Session-by-session alternation among conditions will occur in a unique, predetermined, randomized order for each participant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Functional electrical stimulation

2016

Completed Phase 2

~130

0 / 2Eligibility criteria met