This study explores two promising therapies for restoring arm and hand function in people with chronic cervical spinal cord injury (SCI), a condition that affects independence and quality of life. It will compare transcutaneous spinal cord stimulation and paired corticospinal-motoneuronal stimulation, both combined with rehabilitation. Using a crossover design, participants will receive each therapy for two months, with a one-month washout period in between. Safety, effectiveness, and patient-reported outcomes like daily living ability and quality of life will be assessed, alongside changes in neural excitability. The results of this study may enable us to tailor treatments to individual needs, promoting personalized care and improved outcomes.
Cervical (C2-C8) level SCI
> 9 months post-injury
Traumatic SCI
AIS A-D
individuals with injury to the nervous system other than to the spinal cord
pregnant
Crossover
Transcutaneous Cervical Spinal Cord Stimulation
Other interventionCervical transcutaneous spinal cord stimulation will be delivered following previously reported guidelines. Circular (1.25") electrodes will be placed over the cervical spinal cord between the C3 and C4 vertebral level, with rectangular return electrodes placed either over the clavicles or iliac crests. Biphasic stimulation will be delivered continuously at 30Hz, with a 1ms pulse width, and overlapping 10kHz carrier frequency (Gelenitis et al 2024; Moritz et al 2024). Stimulation will be delivered at a current intensity below motor threshold, that is below the intensity required to elicit a muscle twitch. Cervical tSCS will be delivered for at least 60 minutes during each training session, and FTP will occur during the active stimulation.
Paired Corticospinal Motoneuronal Stimulation
Other interventionPaired transcranial magnetic stimulation and nerve stimulation will be implemented following a previously-published protocol for individuals with SCI (Jo et al 2023). Two figure-eight coils will be used to deliver bilateral magnetic stimulation of the motor cortex and will be combined with synchronous electrical stimulation of the brachial plexus and ulnar nerves, bilaterally. The timing of stimuli will be determined to ensure that electrical volleys arrive at the corticospinal motoneuronal synapse at an appropriate interval to induce long term potentiation. During each session, 360 paired stimuli will be delivered at a frequency of 0.2 Hz. The stimulation paradigm should take approximately 30 minutes. Following this, participants will then complete 60 minutes of FTP.
Functional Task Practice
Other interventionA typical rehabilitation program will be defined and delivered in consultation with physical and occupational therapists. The program will consist of functional tasks including repetitive activities of gross upper extremity movement, isolated finger movements, simple and complex pinch, and grasping activities. For each category, 4-10 activities with various difficulty levels will be identified. Each participant will perform at least 1-2 exercises within each category during each treatment session. Activities in each category will be chosen according to the participants' ability and adjusted based on the evolution of the ability to perform the functional task over time (graded training).
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
The ISNCSCI and its associated subscores related to upper extremity motor and sensory scores will be completed by a blinded assessor.
Graded Redefined Assessment of Strength Sensation and Performance (GRASSP)
The GRASSP will be assessed by a blinded assessor to evaluate changes in strength, sensation and performance of the upper extremities.
Spinal excitability - Cervical Multisegmental Motor Responses (cMMR)
Electrical stimulation to cervical dorsal roots via electrodes placed over the midline of the spinal cord will be used to evaluate changes in cervical spinal cord excitability from the intervention. Recruitment curves will be performed by progressively increasing the stimulation intensity until a plateau in evoked response or reached, or until participant tolerance is reached.
Corticospinal Excitability-Transcranial magnetic stimulation (TMS)
TMS of the cortex has been used extensively in humans to assess the integrity of the descending corticospinal tract (Di Lazzaro et al 2008). Participants will be seated in their wheelchair. Single pulse TMS will be delivered at increasing stimulation intensity, with three stimuli (5s apart) at each intensity, until a plateau in evoked responses is reached, or we reach 100% maximal stimulator output or participant tolerability. Surface EMG will be recorded from multiple upper extremity muscles, bilaterally.
SCIM III
The SCIM III is a validated survey for people with SCI that assesses independence during activities of daily living such as self-care, respiration and sphincter management and mobility. Participants will complete this survey themselves.
WHOQoL-BREF
The WHOQoL-BREF will be self-reported by participants to assess changes in the four domains: physical, psychological, social and environment.
Patient Global Impression of Change (PGIC) Score
Participant will self-report their impressions of change upon completion of each phase of the interventional crossover study.
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Praxis Spinal Cord Institute
Collaborator
