Spinal cord stimulation at two sites for people with spinal cord injury

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have had a spinal cord injury for more than 2 years. They will get a spinal cord stimulator implanted during surgery.

Age

18 to 70 years

Sex

All sexes can join.

Disease stage

Spinal cord injury for more than 2 years, from an accident or another cause. The injury must be ASIA Impairment Scale A or B, meaning complete or near-complete loss of movement below the injury. General health must be ASA status I-III.

Biomarker or test result

An earlier MRI scan showing how large the spinal cord injury is, done before joining.

Main reasons for not taking part

• Long-term use of opioid pain medicines
• A long-term pain condition (pain lasting over 3 months)
• Alcohol or drug abuse
• Active mental illness that is not being treated

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 70 years old?YesNo

What the trial wants to find out

Spinal cord stimulation (SCS) has been shown in previous studies to be capable of restoring motor and autonomic function in patients with chronic complete spinal cord injury (SCI). Clinical studies have demonstrated that SCS enables activation of previously paralyzed muscles, leading to functional improvements in patients in the chronic stage of paralysis through the delivery of activity-based interventions. For most previous studies on SCS in SCI, stimulation was invariably applied to lumbrosacral plexus only. In this study, after signing the consent form, the patient will be assigned for standard surgery with additional implant of the spinal cord stimulator. The investigators propose to conduct the SCS with three phases. For the first phase, SCS over lumbrosacral spinal cord will be activated for 3 months with appropriate stimulation of lower limb muscles for walking together with physiotherapy of individual muscle groups for walking. For the second phase, SCS over lumbrosacral spinal cord will be stopped. SCS over the injury site will be activated for 3 months with appropriate stimulation of lower limb muscles. For the third phase, SCS over both lumbrosacral spinal cord and injury site of spinal cord will be activated for another 3 months with appropriate stimulation of lower limb muscles.

The group in the trial

• Spinal Cord StimulatorTreatment being tested

  After signing the consent form, the patient will be assigned for standard surgery with additional implant of the spinal cord stimulator. Two percutaneous SCS leads will be placed at the level of SCI. These leads were anchored and were tunneled to subcutaneous space in posterior iliac crest and were connected to impulse generator. Another two percutaneous SCS leads will be placed over the lumbrosacral spinal cord. Intraoperative neurological monitoring will be performed. The aim is to determine spinal segmental mapping and to elicit evoked action potentials with contraction of muscles related to locomotor function of the lower limbs. These leads were anchored and were tunneled to subcutaneous space in posterior iliac crest and were connected to impulse generator.