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NCT05491837
Effects of Intermittent Hypoxia in Upper and Lower Limb Functions in Persons With Incomplete Spinal Cord Injury
NA trial testing Device induce acute intermittent hypoxia 9 % of Oxygen in Incomplete Spinal Cord Injury in 68 participants. Currently enrolling.
30 October 2024
Quick facts
| Lead sponsor | Riphah International University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 68 |
| Start date | 1 January 2023 |
| Primary completion | 30 October 2024 |
| Estimated completion | 4 November 2024 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Device induce acute intermittent hypoxia 9 % of Oxygen
- Normoxia 21% of oxygen
Conditions studied
- Incomplete Spinal Cord Injury — all drugs for Incomplete Spinal Cord Injury →
Sponsor
Riphah International University
Who can join
18 and older, any sex, with Incomplete Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Spinal cord injury (SCI) is a devastating disability with physical, social and vocational consequences. Owing to its overwhelming complications, the cost of treatment and rehabilitation increases constantly. Persons with spinal cord injury are always dependent on their families in most of house hold, recreational and activities of daily life. Majority of SCI are incomplete classification C or D as per American spinal injury Association (ASIA). Due to certain spared pathways intrinsic mechanism of neuroplasticity take place in incomplete spinal cord injuries (iSCI) which is liable for natural recovery, but this potential is limited and often slow. Therefore there is need for some advance therapeutic interventions which may enhance neuroplasticity and improve functional recovery in individuals with iSCI. It has been reported that acute intermittent hypoxia (AIH) increase neuro plasticity by causing release of spinal serotonin which stimulate serotonin type 2 (5-HT2) receptors that undergoes a series of mechanisms which increase brain derived neurotrophic factors (BDNF) which subsequently enhance motor functions of upper and lower limbs in iSCI. Despite of the growing body of literatures supporting that AIH improves both upper limb and lower limb functions along with walking ability and speed. However, their results are limited to small sample size, gender biased and lack of intralimbs assessment. As per the author knowledge, these literatures lack retention effects of AIH on upper and lower limb function. In addition variables like quality of life, disability and some biomarkers related to hypoxic effects have not been reported in any of these studies. Furthermore, it is hypothesized that variant geographic locations and socioeconomic status may affects persons with iSCI differently. So in light of these literature gaps, the author aim is to investigate the effects of AIH in upper and lower limb motor function, balance, quality of life and disability. In addition, the effects of AIH on brain derived neurotrophic factors (BDNF), hemoglobin (Hb) level, numbers of RBS and hematocrits will be assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05491837
- Europe PMC full search
- ASCO Meeting Library
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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 NCT05491837 (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 Riphah International University
- Last refreshed: 4 September 2024
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