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Electrical Stimulation for Spasticity in Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TENS
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

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

Inclusion Criteria:

  • SCI adults 18 years and older
  • injury levels between C5-T12

Exclusion Criteria:

  • severe head injury
  • uncontrolled autonomic dysreflexia
  • other medical conditions precluding TENS

Sites / Locations

  • University of Alberta - 524 HMRC

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Participants will not receive intervention for the first 2 months. This period will be used for comparison with the intervention group. At the end of the 2-month delay, they will receive TENS (1 hr AM, 1 hr PM/day, 50 Hz, below pain/motor threshold, using an EMS 7500 TENS unit).

Participants will receive 2 months of TENS (1 hr AM, 1 hr PM/day, 50 Hz, below pain/motor threshold, using an EMS 7500 TENS unit) immediately upon entry to the study.

Outcomes

Primary Outcome Measures

Change in Modified Ashworth Score
Clinical assessment of spasticity. Scores range from '0' to '4'. Minimum score is '0' meaning no increase in tone. Maximum score is '4' meaning limb is ridged in flexion and extension. The lower the score the better the outcome.

Secondary Outcome Measures

Change in Knee Pendulum Angle
Clinical assessment of passive knee motion to assess spasticity.
Change in Manual Muscle Testing
Clinical assessment of muscle strength from grade '0' to '5', where '0' means no strength and '5' means normal strength.
Change in EMG
Assessment of motor control. Participants are asked to match their muscle contraction force to a target force profile. EMG data will be used to calculate the smoothness of muscle force.
Change in International Standard for Neurological Classification of SCI (ISNCSI)
Neurological Examination of participant. The Impairment Scale has 5 grades from A to E. Grade A is complete injury and grade E is normal. It is based on the strength of 10 key muscle groups in the upper and lower extremities, sensory response to light touch and pin prick at 28 key sensory points on each side of the whole body, and anal responses.

Full Information

First Posted
October 7, 2021
Last Updated
November 25, 2022
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05103436
Brief Title
Electrical Stimulation for Spasticity in Spinal Cord Injury
Official Title
Electrical Stimulation for Spasticity in Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study examines the immediate and long-term effects of lumbosacral TENS on spasticity and residual voluntary force control in spinal cord injury in comparison to no TENS. Participants in the intervention group will receive 2 months of TENS. Participants in the control group will receive TENS after a 2-month delay. Modified Ashworth score and pendulum test will be used to assess spasticity and force control. Electrophysiological measures will be used to assess the activity profile of motorneurons.
Detailed Description
Transcutaneous electrical nerve stimulation (TENS) has been used to control pain in stroke, MS, cerebral palsy and spinal cord injury (SCI) and its effect on spasticity reduction, although not used clinically, has been examined recently. In the few SCI studies done to date, the TENS electrodes have been placed on the nerve to the muscle under study and initial reports show a consistent decrease in spasticity measures, like the Modified Ashworth Score (MAS) and reflexes, during or hours after the TENS application. Recently, study team members from the ReYu Recovery Centre in Edmonton have observed that when TENS is applied with both electrodes over the lower back (lumbosacral TENS), varying amounts of immediate and long-term spasticity relief are produced in both legs. The investigators have observed 3 clients from ReYU and all have shown immediate reductions in spasticity for at least 2 joints in both legs. The effect of the lumbosacral TENS varied from an immediate dramatic reduction to a more moderate reduction when applied over several days. This study will examine the immediate and longer-term (2 months) effect of using spinal TENS in reducing spasticity of the lower limbs in a larger number of participants with SCI. The investigators want to understand how spinal TENS affects spinal circuits and motoneurons below the lesion to reduce spasticity to observe improvement in its effect in those with more moderate responses. Lumbosacral TENS has the potential for a non-pharmacological, on-demand control of SCI spasticity to greatly improve the quality of life of those affected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either receive 2 months of TENS (1 hr AM, 1 hr PM/day, 50 Hz, below pain/motor threshold, using a EMS 7500 TENS unit) upon entry to the study (Intervention group) or not (Control; but offered the same TENS following a 2-month delay for equipoise).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will not receive intervention for the first 2 months. This period will be used for comparison with the intervention group. At the end of the 2-month delay, they will receive TENS (1 hr AM, 1 hr PM/day, 50 Hz, below pain/motor threshold, using an EMS 7500 TENS unit).
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants will receive 2 months of TENS (1 hr AM, 1 hr PM/day, 50 Hz, below pain/motor threshold, using an EMS 7500 TENS unit) immediately upon entry to the study.
Intervention Type
Other
Intervention Name(s)
TENS
Intervention Description
Electrical nerve stimulation
Primary Outcome Measure Information:
Title
Change in Modified Ashworth Score
Description
Clinical assessment of spasticity. Scores range from '0' to '4'. Minimum score is '0' meaning no increase in tone. Maximum score is '4' meaning limb is ridged in flexion and extension. The lower the score the better the outcome.
Time Frame
Pre Intervention. 1, 2 and 4 months follow up. In addition, spasticity will be measured every 2 weeks to assess stability of the effects.
Secondary Outcome Measure Information:
Title
Change in Knee Pendulum Angle
Description
Clinical assessment of passive knee motion to assess spasticity.
Time Frame
Pre Intervention. 1, 2 and 4 months follow up.
Title
Change in Manual Muscle Testing
Description
Clinical assessment of muscle strength from grade '0' to '5', where '0' means no strength and '5' means normal strength.
Time Frame
Pre Intervention. 1, 2 and 4 months follow up.
Title
Change in EMG
Description
Assessment of motor control. Participants are asked to match their muscle contraction force to a target force profile. EMG data will be used to calculate the smoothness of muscle force.
Time Frame
Pre Intervention. 1, 2 and 4 months follow up.
Title
Change in International Standard for Neurological Classification of SCI (ISNCSI)
Description
Neurological Examination of participant. The Impairment Scale has 5 grades from A to E. Grade A is complete injury and grade E is normal. It is based on the strength of 10 key muscle groups in the upper and lower extremities, sensory response to light touch and pin prick at 28 key sensory points on each side of the whole body, and anal responses.
Time Frame
Pre Intervention. 1, 2 and 4 months follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: SCI adults 18 years and older injury levels between C5-T12 Exclusion Criteria: severe head injury uncontrolled autonomic dysreflexia other medical conditions precluding TENS
Facility Information:
Facility Name
University of Alberta - 524 HMRC
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only the investigators of this study and the University of Alberta Research Ethics Board will have access to participant information. Only de-identified data will be presented or published.

Learn more about this trial

Electrical Stimulation for Spasticity in Spinal Cord Injury

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