Transcranial Electrical Stimulation for Management of Orthostatic Instability in Acute Cervical Spinal Cord Injury

NCT ID: NCT01874782

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-07-31

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

Conditions

Orthostatic Hypotension; Postural Hypotension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcranial electrical stimulation

Subject 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-).

Group Type: EXPERIMENTAL

transcranial electrical stimulation

Intervention Type: DEVICE

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).

Interventions

transcranial electrical stimulation

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).

Intervention Type: DEVICE

Other Intervention Names

TRANSAIR (TES Center, St Petersburg, Russia)

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vancouver Coastal Health Research Institute

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Patricia Mills

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia B Mills, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

GF Strong Rehabilitation Center - Vancouver Coastal Health Research Institute

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H12-03534

Identifier Type: -

Identifier Source: org_study_id