Controlling Orthostatic Hypotension in People with Cervical Spinal Cord Injury

NCT04369131 | Withdrawn FDA Device

• 1 other identifier: Xcite study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A common therapeutic intervention after spinal cord injury (SCI) is prolonged standing in a standing frame. For people with SCI, standing for 40 minutes or more, three to four times weekly improves several health-related issues including well-being, circulation, skin integrity, reflex activity, bowel and bladder function, digestion, sleep, pain, and fatigue. However, a person who experiences orthostatic hypotension (OH)-defined as a decrease of 20mm hg in systolic blood pressure or a decrease of 10mm hg in diastolic pressure within 3 minutes of standing from a sitting or supine position-secondary to SCI may not tolerate positioning in a standing frame, thus resulting in a loss of access to these health benefits. OH is common for people with SCI. It results from central nervous system dysregulation causing pooling of blood in the lower extremities that can lead to dizziness, light-headedness, blurred vision, weakness, fatigue, nausea, palpitations, headache, and/or syncope. Although an array of physical and pharmacologic interventions are available to people in the general population for managing OH, few such interventions have been evaluated for use by people with SCI, especially when the level of injury is C5 or above. One possible intervention that may be effective for people with OH secondary to SCI is functional electrical stimulation (FES) because its application results in a dose-dependent increase in blood pressure. An unanswered question is whether the placement of FES electrodes on various parts of the body has differential effects. Therefore, the purpose of this study is to evaluate blood pressure responses among people with OH secondary to cervical SCI when receiving FES intervention involving the placement of electrodes in three different positions as well as when receiving no FES intervention during tilt table sessions. The selected positions for electrode placement are: (a) the calves, (b) the quads and abdominals, and (c) the quads, abdominals, and calves. The researchers hypothesize that FES intervention, regardless of placement, will result in better control of OH than no FES intervention and that no significant blood pressure difference will occur across the three FES placements.

Conditions

Spinal Cord Injury Cervical; Hypotension, Orthostatic

Keywords

Spinal cord injury; Orthostatic hypotension; Functional electrical stimulation

Outcome Measures

Primary Outcomes (2)

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

  Maximum tilt table angle, ranging from 0 to 90 degrees, tolerated by participant during each session

  Measured over the course of each one hour tilt table session

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

  Systolic and diastolic blood pressure values measured in millimeters of mercury

  Measured every three minutes throughout the time a participant is positioned on the tilt table

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Device: Functional electrical stimulation

Interventions

Functional electrical stimulation DEVICE

Randomized placement of FES pads in one of four locations during each session. Locations include: (a) none, (b) calves only, (c) quads and abdominals only, and (d) calves, quads, and abdominals.

Intervention

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult resident of Quality Living, Inc.
• SCI at the level of C5 or higher
• experience OH upon rising from a sitting or supine position
• comprehend English sufficiently to understand the consent form as measured by responses to included questions

You may not qualify if:

• any person who has a legally authorized representative responsible for making healthcare decisions because of compromised cognitive or communication status
• any person for whom FES is contraindicated as determined by the physiatrist responsible for monitoring the health and rehabilitation programs of Quality Living residents

Sponsors & Collaborators

• Quality Living, Inc.: lead

Study Sites (1)

Quality Living, Inc.

Omaha, Nebraska, 68104, United States

Location

Related Publications (3)

• Chi L, Masani K, Miyatani M, Adam Thrasher T, Wayne Johnston K, Mardimae A, Kessler C, Fisher JA, Popovic MR. Cardiovascular response to functional electrical stimulation and dynamic tilt table therapy to improve orthostatic tolerance. J Electromyogr Kinesiol. 2008 Dec;18(6):900-7. doi: 10.1016/j.jelekin.2008.08.007. Epub 2008 Oct 2.

  PMID: 18835189 BACKGROUND

• Eng JJ, Levins SM, Townson AF, Mah-Jones D, Bremner J, Huston G. Use of prolonged standing for individuals with spinal cord injuries. Phys Ther. 2001 Aug;81(8):1392-9. doi: 10.1093/ptj/81.8.1392.

  PMID: 11509069 BACKGROUND

• Sampson EE, Burnham RS, Andrews BJ. Functional electrical stimulation effect on orthostatic hypotension after spinal cord injury. Arch Phys Med Rehabil. 2000 Feb;81(2):139-43. doi: 10.1016/s0003-9993(00)90131-x.

  PMID: 10668765 BACKGROUND

Related Links

• Evaluation and Management of Orthostatic Hypotension

MeSH Terms

Conditions

Hypotension, Orthostatic; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Karen Hux, Ph.D.

  Quality Living, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: Participants will engage in three baseline sessions to document blood pressure fluctuations associated with central nervous system dysregulation when changing from a sitting or supine position to a standing position involving the use of a head-up tilt table and no FES. Then, participants will engage in tilt table sessions in which the researchers randomly alternate the placement of FES pads across four conditions: (a) no FES, (b) calves only FES, (c) quads and abdominal only FES, and (d) calves, quads, and abdominal FES. Sessions will occur three to four times weekly until a participant demonstrates no OH upon tilt table adjustment to 90° (i.e., upright position) or the participant discharges from Quality Living, Inc., whichever comes first.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 30, 2020
• Study Start: December 1, 2021
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)