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Electrical Stimulation for Spinal Cord Injury

N/A

Waitlist Available

Led By Monica Gorassini, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre intervention. 1, 2 and 4 months follow up. in addition, spasticity will be measured every 2 weeks to assess stability of the effects.

Awards & highlights

Study Summary

This trialexamines the effects of TENS on spasticity & force control in spinal cord injury. Modified Ashworth Score & pendulum test used, electrophysiological measures to assess motorneuron activity. Intervention group gets 2 months of TENS, control group 2 months later.

Who is the study for?

Adults over 18 with spinal cord injuries between the neck and mid-back (C5-T12 levels) can join this trial. It's not for those who've had a severe head injury, uncontrolled blood pressure spikes due to nerve issues (autonomic dysreflexia), or conditions that make TENS unsafe.Check my eligibility

What is being tested?

The study is testing if lumbosacral TENS, an electrical stimulation therapy, can reduce muscle stiffness (spasticity) and improve voluntary muscle control in people with spinal cord injuries. One group gets TENS for two months; another waits two months before receiving it.See study design

What are the potential side effects?

TENS is generally safe but may cause skin irritation under the pads, tingling sensations during use, or muscle twitching. Rarely, it might lead to discomfort or pain at the stimulation site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre intervention. 1, 2 and 4 months follow up. in addition, spasticity will be measured every 2 weeks to assess stability of the effects.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre intervention. 1, 2 and 4 months follow up. in addition, spasticity will be measured every 2 weeks to assess stability of the effects.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre intervention. 1, 2 and 4 months follow up. in addition, spasticity will be measured every 2 weeks to assess stability of the effects. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Modified Ashworth Score

Secondary outcome measures

Change in EMG

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

Change in Knee Pendulum Angle

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Control GroupActive Control1 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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,137 Total Patients Enrolled

Monica Gorassini, PhDPrincipal InvestigatorUniversity of Alberta

4 Previous Clinical Trials

58 Total Patients Enrolled

Media Library

TENS (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05103436 — N/A

Spinal Cord Injury Research Study Groups: Control Group, Intervention Group

Spinal Cord Injury Clinical Trial 2023: TENS Highlights & Side Effects. Trial Name: NCT05103436 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment opportunities for this trial?

"As listed on clinicaltrials.gov, this particular medical experiment is not currently recruiting participants. The trial was first posted in May of 2022 and last updated at the end of November that same year. Despite its closure for recruitment, there are 903 other studies which remain open to new patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Electrical Stimulation for Spasticity in Spinal Cord Injury

Monica Gorassini 2022. "Electrical Stimulation for Spasticity in Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05103436.

All > Spinal Cord Injury