Electrical Stimulation for Spasticity in Spinal Cord Injury

NCT05103436 | Active Not Recruiting

• 1 other identifier: Pro00112681
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (4)

• Change in Knee Pendulum Angle

  Pre Intervention. 1, 2 and 4 months follow up.

• Change in Manual Muscle Testing

  Pre Intervention. 1, 2 and 4 months follow up.

• Change in EMG

  Pre Intervention. 1, 2 and 4 months follow up.

• Change in International Standard for Neurological Classification of SCI (ISNCSI)

  Pre Intervention. 1, 2 and 4 months follow up.

Study Arms (2)

Control Group

NO INTERVENTION

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).

Intervention Group

EXPERIMENTAL

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

Interventions

TENS OTHER

Electrical nerve stimulation

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta - 524 HMRC

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Monica Gorassini, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 2, 2021
• Study Start: May 4, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)