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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Collaborator:
Vancouver Coastal Health Research Institute
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01874782
First received: February 12, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Orthostatic Hypotension
Postural Hypotension
Device: transcranial electrical stimulation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transcranial Electrical Stimulation for Management of Orthostatic Instability in Acute Cervical Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in orthostatic decrease in BP in response to six sessions of TES, determined via the established bedside sit-up test [ Time Frame: The change in BP will be measured between time points: 1. immediately before first TES session and 2. immediately after last TES session. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Long term change in BP. [ Time Frame: Change in BP between timepoints 1. immediately before first TES session and 2. 3 weeks after last TES session. ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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-).
Device: 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).
Other Name: TRANSAIR (TES Center, St Petersburg, Russia)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874782

Contacts
Contact: Patricia B Mills, MD FRCPC 778-233-6222 patricia.mills@vch.ca
Contact: Andrei Krassioukov, MD PhD FRCPC 604-675-8819 andrei.krassioukov@vch.ca

Locations
Canada, British Columbia
GF Strong Rehabilitation Center - Vancouver Coastal Health Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Principal Investigator: Patricia B Mills, MD FRCPC         
Sub-Investigator: Andrei Krassioukov, MD PhD FRCPC         
Sub-Investigator: Darren Gray, MD         
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
Investigators
Principal Investigator: Patricia B Mills, MD FRCPC University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01874782     History of Changes
Other Study ID Numbers: H12-03534
Study First Received: February 12, 2013
Last Updated: June 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
spinal cord injury
cardiovascular
orthostatic hypotension
transcranial electrical stimulation
electrotherapy

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014