This clinical trial investigates whether combining cortical and spinal neuromodulation can improve upper limb motor recovery in adults with chronic incomplete cervical spinal cord injury (SCI). Restoring upper limb function is the top rehabilitation priority for individuals with tetraplegia, yet effective interventions remain limited.
The study combines transcutaneous spinal cord stimulation (tSCS), which enhances spinal circuit excitability, with intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation that increases cortical excitability and strengthens descending motor pathways. While each approach has shown independent promise, their combined use has not been evaluated in a controlled trial.
Eligible participants are adults aged 21-65 with chronic (\>12 months post-injury) incomplete cervical SCI (ASIA Impairment Scale grade C or D, levels C2-C8). A total of 24 participants will be randomised 1:1 to either combined iTBS and tSCS plus standardised upper limb rehabilitation, or tSCS plus rehabilitation alone, across 24 sessions over 12 weeks.
The primary outcome is change in Upper Extremity Motor Score from baseline to week 12. Secondary outcomes cover functional performance, independence, spasticity, corticospinal excitability, quality of life, and goal attainment. Assessments occur at baseline, post-intervention, and at 4- and 12-week follow-up.
As a pilot randomised controlled trial, this study will generate the first controlled evidence on adjunctive cortical neuromodulation alongside tSCS-based rehabilitation, while also producing feasibility data to inform the design of a future definitive multicentre trial.
Chronicity: More than 12 months post-injury at enrollment
Injury type: Traumatic or non-traumatic incomplete cervical SCI, neurological level C2 to C8
AIS classification: Grade C or D
UEMS: 10 to 20 out of 25 on the more impaired side; lower bound 10 ensures sufficient voluntary activation for task training and elicitable MEPs, upper bound avoids ceiling effects.
Seizure history: History of seizures or epilepsy
Implanted devices: Intracranial metallic implants, cochlear implants, cardiac pacemakers, or other implanted electronic devices. Cervical spinal instrumentation (e.g., posterior rods, plates, or screws at C2 to T1) is not an exclusion for tSCS provided overlying skin is intact; participants with hardware directly beneath planned electrode sites will undergo low-intensity test stimulation during screening, and electrode placement will be shifted by one interspace if current distortion, focal discomfort, or unexpected motor thresholds are observed. Intracranial hardware remains an absolute exclusion for iTBS.
Prior craniotomy: Prior neurosurgical procedure involving craniotomy
Pregnancy: Currently pregnant or intending to become pregnant during the study period
Parallel
Transcranial Magnetic Stimulation
DeviceRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that enhances cortical excitability and corticospinal drive. Intermittent theta burst stimulation (iTBS), a brief patterned form of rTMS, produces lasting facilitatory effects and is more time-efficient. Evidence indicates rTMS improves motor function, reduces spasticity, and enhances neuroplasticity in SCI.
Transcutaneous Spinal Cord Stimulation
DeviceTranscutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that delivers electrical stimulation over the spine to activate sensory afferents and enhance spinal motor circuit excitability. Early studies showed it can enable voluntary movement even in motor-complete spinal cord injury (SCI), with subsequent research demonstrating improvements in motor function, standing, and walking in incomplete SCI. Evidence suggests tSCS modulates both spinal and corticospinal pathways, supporting neuroplasticity. The Up-LIFT trial (2024) provided strong clinical evidence, showing that tSCS combined with rehabilitation significantly improved upper limb strength and function in chronic cervical SCI, with 72% of participants meeting effectiveness endpoints and no serious adverse events. Later studies confirmed its safety in home and community settings, though standardization and larger trials remain needed.
Upper Extremity Motor Score (UEMS)
The UEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination and assesses the strength of 10 key muscles of the upper extremities (5 per side) on a 0 to 5 scale, yielding a score of 0 to 25 per side or 0 to 50 bilaterally. The UEMS has well-established psychometric properties, is sensitive to change in SCI populations. Higher score indicates better outcomes.
Upper Extremity Motor Score (UEMS)
The UEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination and assesses the strength of 10 key muscles of the upper extremities (5 per side) on a 0 to 5 scale, yielding a score of 0 to 25 per side or 0 to 50 bilaterally. The UEMS has well-established psychometric properties, is sensitive to change in SCI populations. Higher score indicates better outcomes.
Upper Extremity Motor Score (UEMS)
The UEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination and assesses the strength of 10 key muscles of the upper extremities (5 per side) on a 0 to 5 scale, yielding a score of 0 to 25 per side or 0 to 50 bilaterally. The UEMS has well-established psychometric properties, is sensitive to change in SCI populations. Higher score indicates better outcomes.
Upper Extremity Motor Score (UEMS)
The UEMS is a component of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination and assesses the strength of 10 key muscles of the upper extremities (5 per side) on a 0 to 5 scale, yielding a score of 0 to 25 per side or 0 to 50 bilaterally. The UEMS has well-established psychometric properties, is sensitive to change in SCI populations. Higher score indicates better outcomes.
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Version 2 (GRASSP-2)
The GRASSP V2 is an assessment for tetraplegia, typically scored across 5 specific subtests rather than a single total sum. Key maximum scores for GRASSP V2 include 50 for Strength (10 muscles x 5), 12 for Dorsal Sensation, 12 for Palmar Sensation, and 30 for Prehension Performance. A higher score indicates better outcomes.
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Version 2 (GRASSP-2)
The GRASSP V2 is an assessment for tetraplegia, typically scored across 5 specific subtests rather than a single total sum. Key maximum scores for GRASSP V2 include 50 for Strength (10 muscles x 5), 12 for Dorsal Sensation, 12 for Palmar Sensation, and 30 for Prehension Performance. A higher score indicates better outcomes.
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Version 2 (GRASSP-2)
The GRASSP V2 is an assessment for tetraplegia, typically scored across 5 specific subtests rather than a single total sum. Key maximum scores for GRASSP V2 include 50 for Strength (10 muscles x 5), 12 for Dorsal Sensation, 12 for Palmar Sensation, and 30 for Prehension Performance. A higher score indicates better outcomes.
Graded and Redefined Assessment of Strength, Sensibility, and Prehension Version 2 (GRASSP-2)
The GRASSP V2 is an assessment for tetraplegia, typically scored across 5 specific subtests rather than a single total sum. Key maximum scores for GRASSP V2 include 50 for Strength (10 muscles x 5), 12 for Dorsal Sensation, 12 for Palmar Sensation, and 30 for Prehension Performance. A higher score indicates better outcomes.
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