Transcranial Electrical Stimulation for Management of Orthostatic Instability in Acute Cervical Spinal Cord Injury
1 other identifier
interventional
4
1 country
1
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 sitting or standing, a condition also known as orthostatic hypotension (OH). Due to a decrease in cerebral oxygenation, affected individuals can develop debilitating symptoms including lightheadedness, blurred vision, fatigue and even loss of consciousness. Recent evidence suggests that OH has a negative impact on cognition in individuals with SCI. Clinical observations suggest that OH can lead to neurological deterioration in individuals who may otherwise have a stable SCI. The presence of symptomatic OH prevented participation in 43% of physical therapy treatment sessions in a study of individuals with acute SCI despite the use of current treatment options. OH is known to adversely affect health, delay rehabilitation and prolong hospitalization in the acute phase of management of individuals who display it. Our team found OH was present in 41 of 55 (75%) patients with acute cervical SCI at our center in 2004. We plan to research the efficacy of a low-cost, non-invasive device known as transcranial electrical stimulation (TES) to manage OH in individuals with acute cervical SCI. Previous studies have shown that this device is safe to use in individuals with SCI, and has improved blood pressure control in non-SCI individuals. We hypothesize that in individuals with acute cervical SCI and OH, TES intervention will elicit an attenuation of the drop in systolic BP (SBP)in response to orthostatic stress. TES-induced differences will be most pronounced in those individuals with sparing of spinal autonomic pathways
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedApril 23, 2019
April 1, 2019
2.2 years
February 12, 2013
April 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in orthostatic decrease in BP in response to six sessions of TES, determined via the established bedside sit-up test
In brief, the subject will receive six sessions of thirty minutes duration of transcranial electrical stimulation. Immediately after the last session, the subject will be monitored via finger BP cuff in the supine position for 10 minutes resting BP. Next the subject will be transferred to the sit-up position with continuous BP recording. The decline in BP at three minutes (orthostatic decrease) following assumption of the sit-up posture will be documented.
The change in BP will be measured between time points: 1. immediately before first TES session and 2. immediately after last TES session.
Secondary Outcomes (1)
Long term change in BP.
Change in BP between timepoints 1. immediately before first TES session and 2. 3 weeks after last TES session.
Study Arms (1)
Transcranial electrical stimulation
EXPERIMENTALSubject will be determined as autonomically complete or incomplete injury with measuring of the sympathetic skin responses (SSR+), an established protocol for measuring integrity of sympathetic spinal pathways, versus complete autonomic injury (SSR-).
Interventions
TES: medical device TRANSAIR: electrodes placed on the forehead and over the mastoid processes using Velcro straps. Treatment protocol: six 30-minute sessions over a two-week period and stimulation variables (bipolar current; 1.0-3.0 milliamp (mA) amplitude, 3.5 ms duration and 77.5 Hz frequency).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GF Strong Rehabilitation Center - Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 2G9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia B Mills, MD FRCPC
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 12, 2013
First Posted
June 11, 2013
Study Start
May 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
April 23, 2019
Record last verified: 2019-04