← Back to Search

Behavioural Intervention

Non-Invasive Stimulation for Spinal Cord Injury

Phase 2

Waitlist Available

Research Sponsored by Kathleen Friel

Eligibility Criteria Checklist

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

Must have

Motor incomplete lesion, measured by the American Spinal cord Injury Association (ASIA) Impairment Scale (AIS)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately after intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a specific type of stimulation can increase spinal excitability and improve motor recovery.

Who is the study for?

This trial is for individuals with chronic spinal cord injuries (more than 6 months old) who still have some motor function in their ankle muscles. Participants must have an incomplete lesion as classified by the ASIA Impairment Scale and a traumatic cause for their injury.

What is being tested?

The study is testing Spinal Associative Stimulation (SAS), which combines Transcranial Magnetic Stimulation (TMS) with Peripheral Nerve Stimulation to see if it can increase spinal excitability and improve motor recovery in participants.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however, these are generally rare. The non-invasive nature of TMS & Peripheral Nerve Stimulation typically results in fewer side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My spinal cord injury is partially impairing my movement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in H-Reflex Threshold

Secondary study objectives

10 Meter Walk Test

Anklebot

Lower Extremity

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: SAS20Experimental Treatment1 Intervention

The paired stimulation (SAS) will be comprised of patient adjusted subthreshold TMS (80% of resting motor threshold over optimal site for soleus muscle), delivered 20ms prior to a peripheral nerve stimulus in the popliteal fossa and will be repeated at 0.1 Hz for 15 minutes (90 stimuli pairs).

Group II: SAS0Active Control1 Intervention

The paired stimulation (SAS) will be comprised of patient adjusted subthreshold TMS (80% of resting motor threshold over optimal site for soleus muscle), delivered 0ms prior to a peripheral nerve stimulus in the popliteal fossa and will be repeated at 0.1 Hz for 15 minutes (90 stimuli pairs).

Group III: SAS50Active Control1 Intervention

The paired stimulation (SAS) will be comprised of patient adjusted subthreshold TMS (80% of resting motor threshold over optimal site for soleus muscle), delivered 50ms prior to a peripheral nerve stimulus in the popliteal fossa and will be repeated at 0.1 Hz for 15 minutes (90 stimuli pairs).

0 / 1Eligibility criteria met