Biofeedback training for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord Injuries+5 More
Biofeedback training - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether an intervention using biofeedback can help manage stress and anxiety for people with tetraplegia. It will last 5 weeks, with participants having two sessions a week that will last around 30 minutes each.

Eligible Conditions
  • Spinal Cord Injuries
  • Stress (Psychology)
  • Quadriplegia
  • Anxiety

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)

Week 1
Brief Pain Inventory (BPI) - pain relief item
Week 1
Symptom list
Week 1
State Trait Anxiety Inventory (STAI)
Week 4
Brief Pain Inventory (BPI) - 4 pain severity items
Change in Depression Anxiety Stress Scale-21 (DASS-21) scores
Change in Subjective Units of Distress Scale (SUDS) scores
Week 1
Brief Pain Inventory (BPI) - current pain severity item
Week 4
Change in physiological stress
Session #8 (week 4)
Impact of study participation

Trial Safety

Trial Design

2 Treatment Groups

Control Group
1 of 2
Biofeedback
1 of 2

Active Control

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Biofeedback training · No Placebo Group · N/A

BiofeedbackExperimental Group · 2 Interventions: Biofeedback training, Psychophysiological monitoring · Intervention Types: Behavioral, Behavioral
Control Group
Behavioral
ActiveComparator Group · 1 Intervention: Psychophysiological monitoring · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biofeedback training
2013
N/A
~370

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: after intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)

Who is running the clinical trial?

Craig HospitalLead Sponsor
34 Previous Clinical Trials
8,018 Total Patients Enrolled
17 Trials studying Spinal Cord Injuries
1,356 Patients Enrolled for Spinal Cord Injuries

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person is willing to download the Zoom videoconferencing software.
You have tetraplegia with residual sensory or motor impairments.
, many chronic pain patients continue to experience uncontrolled pain that greatly diminishes their quality of life
is becoming more common High-speed internet access is becoming more common in homes.
You have access to a mobile phone and are willing to download HRV software.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.