Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electrical Stimulation for Spasticity in Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05103436
Recruitment Status : Active, not recruiting
First Posted : November 2, 2021
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: TENS Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Electrical Stimulation for Spasticity in Spinal Cord Injury
Actual Study Start Date : May 4, 2022
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Control Group
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).
Experimental: Intervention Group
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.
 Other: TENS
Electrical nerve stimulation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Modified Ashworth Score [ 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. ]
    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 :
  1. Change in Knee Pendulum Angle [ Time Frame: Pre Intervention. 1, 2 and 4 months follow up. ]
    Clinical assessment of passive knee motion to assess spasticity.

  2. Change in Manual Muscle Testing [ Time Frame: Pre Intervention. 1, 2 and 4 months follow up. ]
    Clinical assessment of muscle strength from grade '0' to '5', where '0' means no strength and '5' means normal strength.

  3. Change in EMG [ Time Frame: Pre Intervention. 1, 2 and 4 months follow up. ]
    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.

  4. Change in International Standard for Neurological Classification of SCI (ISNCSI) [ Time Frame: Pre Intervention. 1, 2 and 4 months follow up. ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05103436


Locations
Layout table for location information
Canada, Alberta
University of Alberta - 524 HMRC
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT05103436    
Other Study ID Numbers: Pro00112681
First Posted: November 2, 2021    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System