Combined TMS-tSCS for Lower Limb Rehabilitation in Chronic Incomplete SCI

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational University Hospital, Singapore

About this trial

he goal of this clinical trial is to learn if combined brain and spinal cord stimulation using TMS-tSCS can improve leg strength and walking recovery in adults with chronic incomplete spinal cord injury.

The main questions it aims to answer are:

Does combined TMS-tSCS improve lower limb motor function more than tSCS alone? Is combined TMS-tSCS safe and does it improve walking speed, independence, muscle activity, spasticity, and nerve pathway function?

Researchers will compare combined TMS-tSCS with tSCS alone with sham TMS to see if adding brain stimulation leads to better recovery than spinal stimulation alone.

Participants will:

Attend 32 treatment sessions over 16 weeks. Receive either combined TMS-tSCS or tSCS with sham TMS. Undergo assessments of leg strength, walking speed, daily function, muscle stiffness, muscle activity, and nerve pathway function before and after treatment.

Eligibility criteria

Qualifiers

Age 18-65 years at enrolment

Chronic traumatic spinal cord injury, defined as ≥12 months post-injury

Incomplete spinal cord injury, AIS grade C or D

Neurological level of injury from C2 to L1

Disqualifiers

History of seizures or epilepsy

Implanted electronic devices, such as: Pacemaker, Cochlear implant, Deep brain stimulator, Spinal cord stimulator, Metallic implants in the head or spine

Pregnancy or planned pregnancy

Active psychiatric disorder or cognitive impairment

Trial design

Treatments tested in this trial

  • Transcranial Magnetic Stimulation
  • Transcutaneous Spinal Cord Stimulation

Treatment groups

24 Participants
are divided into 2 treatment groups