Status:
COMPLETED
Transcranial Electrical Stimulation for Management of Orthostatic Instability in Acute Cervical Spinal Cord Injury
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Vancouver Coastal Health Research Institute
Conditions:
Orthostatic Hypotension
Postural Hypotension
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Individuals with acute cervical spinal cord injury (SCI) can suffer from an excessive and prolonged fall in blood pressure when assuming an upright position, such as transitioning from lying to sittin...
Eligibility Criteria
Inclusion
- medically stable individuals with acute traumatic cervical SCI with OH;
- age 18-65 years;
- able to give informed consent.
- OH will be defined as per the American Academy of Neurology Consensus as a decrease in systolic BP ≥ 20 mmHg, or diastolic BP ≥ 10 mmHg when assuming an upright position on the sit-up test, whether or not symptoms occur.
Exclusion
- individuals with: any clinically important or unstable medical or psychiatric disorders;
- history of seizures;
- neuropsychiatric comorbidity;
- acute conditions that could exacerbate cardiovascular control, ie: untreated urinary tract or chest infections, open wounds, etc;
- alterations in head computed tomography or head MRI;
- any cognitive dysfunction or language barrier that would prevent subjects from following English instructions.
- Use of short acting medications for OH (ie: midodrine) will not be a contra-indication as they will be withheld prior to testing, however having continuous administration of vasopressors will be an exclusion criteria.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01874782
Start Date
May 1 2013
End Date
July 1 2015
Last Update
April 23 2019
Active Locations (1)
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1
GF Strong Rehabilitation Center - Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada, V5Z 2G9