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

Primary Purpose

Orthostatic Hypotension, Postural Hypotension

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
transcranial electrical stimulation
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthostatic Hypotension focused on measuring spinal cord injury, cardiovascular, orthostatic hypotension, transcranial electrical stimulation, electrotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GF Strong Rehabilitation Center - Vancouver Coastal Health Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial electrical stimulation

Arm Description

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-).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Long term change in BP.

Full Information

First Posted
February 12, 2013
Last Updated
April 20, 2019
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01874782
Brief Title
Transcranial Electrical Stimulation for Management of Orthostatic Instability in Acute Cervical Spinal Cord Injury
Official Title
Transcranial Electrical Stimulation for Management of Orthostatic Instability in Acute Cervical Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension, Postural Hypotension
Keywords
spinal cord injury, cardiovascular, orthostatic hypotension, transcranial electrical stimulation, electrotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial electrical stimulation
Arm Type
Experimental
Arm Description
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-).
Intervention Type
Device
Intervention Name(s)
transcranial electrical stimulation
Other Intervention Name(s)
TRANSAIR (TES Center, St Petersburg, Russia)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in orthostatic decrease in BP in response to six sessions of TES, determined via the established bedside sit-up test
Description
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.
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia B Mills, MD FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
GF Strong Rehabilitation Center - Vancouver Coastal Health Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada

12. IPD Sharing Statement

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

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