Last reviewed · How we verify
NCT03975075
Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
NA trial testing Psychophysiological monitoring in Spinal Cord Injuries in 30 participants. Completed in 31 January 2023.
31 January 2023
Quick facts
| Lead sponsor | Craig Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 October 2019 |
| Primary completion | 31 January 2023 |
| Estimated completion | 31 January 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Psychophysiological monitoring
- Biofeedback training
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
- Anxiety — all drugs for Anxiety →
- Stress — all drugs for Stress →
- Tetraplegia — all drugs for Tetraplegia →
Sponsor
Craig Hospital
Who can join
Adults 18 to 65, any sex, with Spinal Cord Injuries or Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia. The expected duration of participation in this study is about 5 hours over the course of about 5 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring for the purpose of measuring heart rate and breathing. Those assigned to the biofeedback group will undergo 20 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. Those assigned to the control group will undergo 20 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each session is expected to last 30 minutes to allow for completion of questionnaires over the the phone prior to and following each training session. It is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03975075
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Spinal Cord Injuries
Currently open trials in the same condition.
- NCT07109804 — Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury · NA · recruiting
- NCT07472985 — Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial · NA · recruiting
- NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
- NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
- NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting
Other Craig Hospital trials
Trials by the same sponsor.
- NCT07227727 — Endothelial Dysfunction After SCI · recruiting
- NCT07227740 — Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury · recruiting
- NCT06780280 — Walking With Overground Robotic Exoskeletons to Improve Arrousal in Individuals With Disorders of Consciousness · Phase 2, PHASE3 · not yet recruiting
- NCT06443151 — Role of Endothelial Function in SCI CVD Risk · recruiting
- NCT06276894 — Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03975075 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Craig Hospital
- Last refreshed: 20 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03975075.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing