A pilot study using ExaStim to restore upper limb function after spinal cord injury

Research Objectives: Assess safety and explore efficacy of ExaStim, a wireless, portable multi-electrode neuromodulation system supporting selective non-invasive spinal neuromodulation to restore upper limb function in spinal cord injury (SCI) patients.

Design: A multi-center, prospective, crossover, blinded study.

Setting: Outpatient rehabilitation clinics and hospitals.

Participants: Individual with traumatic chronic SCI between C5 and T2.

Interventions: Physical therapy paired with Sham stimulation for the first 8 weeks followed by second 8 weeks of active therapeutic stimulation. Transcutaneous multi-channel spinal cord neuromodulation is delivered through ExaStim.

Main Outcome Measures: Safety: no serious adverse events, per ISO 14155:2020. Effectiveness: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Upper Extremity Motor Score (UEM) and the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).

Results: A total of 12 subjects were enrolled; nine completed and three withdrew from study participation shortly after beginning study therapy. No serious adverse event was observed during the duration of study. Nine participants treated with ExaStim experienced a median increase in ISNCSCI UEMS total score of 6.0 points from the baseline. For the Neurological Level of Injury assessment of the INSCSCI Score, one subject improved from C4 to C5 and two subjects improved from C6 to C7. For the assessment of the INSCSCI, one subject improved from B to C, one subject improved from C to D, and a third subject improved from A to C. However, due to the large variability in the GRASSP scores obtained using this instrument, no consistent trends could be observed

Conclusions: The pilot study provides preliminary evidence of treatment safety and possible effectiveness using ExaStim to improve upper limb function in individuals with SCI. Further investigation of the device effectiveness and safety is warranted in a larger trial.

Author(s) Disclosures: Dr. Yi-Kai Lo and Rachel Yung are employees of Aneuvo, which owns the intellectual property of the transcutaneous neuromodulation device used in this study.
Drs. Dimitry Sayenko, Rebecca Martin, and Monica Perez received research funding from Aneuvo for this study; Drs. Sayenko and Perez consult for Aneuvo.