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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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Quality Living, Inc.Lead Sponsor

7 Previous Clinical Trials

325 Total Patients Enrolled

Karen Hux, Ph.D.Principal InvestigatorQuality Living, Inc.

4 Previous Clinical Trials

73 Total Patients Enrolled

Media Library

Spinal Cord Injury Research Study Groups: Intervention

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this clinical trial open for participation?

"For enrolment in this medical study, patients should exhibit hypotension and orthostatic symptoms while being of age between 19 to 70. A maximum number of 10 candidates will be accepted into the trial."

Answered by AI

Is this experiment accommodating participants over the age of 80?

"This trial stipulates that only individuals aged 19 to 70 can apply. Those under the age of 18 have 144 trials available, while those over 65 are eligible for 813 different medical studies."

Answered by AI

Are volunteers being accepted into this experiment at present?

"The clinical trial details hosted on the website indicate that recruitment for this particular study has ceased. The project was first announced in December 2021 and last updated in September 2022; however, there are currently 1002 other studies actively looking to enrol volunteers."

Answered by AI

Recent research and studies

Physical TherapyJournal

Use of Prolonged Standing for Individuals with Spinal Cord Injuries

Eng, Janice J, Stephen M Levins, Andrea F Townson, Dianna Mah-Jones, Joy Bremner, and Grant Huston. 2001. “Use of Prolonged Standing for Individuals with Spinal Cord Injuries”. Physical Therapy. Oxford University Press (OUP). doi:10.1093/ptj/81.8.1392.

Journal of Electromyography and KinesiologyJournal

Cardiovascular Response to Functional Electrical Stimulation and Dynamic Tilt Table Therapy to Improve Orthostatic Tolerance

Chi, Lorne, Kei Masani, Masae Miyatani, T. Adam Thrasher, K. Wayne Johnston, Alexandra Mardimae, Cathie Kessler, Joseph A. Fisher, and Milos R. Popovic. 2008. “Cardiovascular Response to Functional Electrical Stimulation and Dynamic Tilt Table Therapy to Improve Orthostatic Tolerance”. Journal of Electromyography and Kinesiology. Elsevier BV. doi:10.1016/j.jelekin.2008.08.007.

Archives of Physical Medicine and RehabilitationJournal

Functional Electrical Stimulation Effect on Orthostatic Hypotension After Spinal Cord Injury

Sampson, Evan E., Robert S. Burnham, and Brian J. Andrews. 2000. “Functional Electrical Stimulation Effect on Orthostatic Hypotension After Spinal Cord Injury”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/s0003-9993(00)90131-x.

clinicaltrials.govStudy