ARCEX Therapy Enhances Arm and Hand Function in Chronic Cervical Spinal Cord Injury

Cervical spinal cord injury (SCI) often leads to significant and lasting impairment of arm and hand functions, severely impacting the quality of life for affected individuals. The development and application of therapeutic interventions to mitigate these impairments have been a major focus of contemporary neurorehabilitation research. One promising avenue is the use of electrical stimulation to enhance neurological recovery. New study published in Nature Medicine and led by Professor Grégoire Courtine from the NeuroX Institute and Brain Mind Institute at the Swiss Federal Institute of Technology (EPFL), evaluated the safety and efficacy of ARCEX Therapy which is a novel approach involving externally applied electrical stimulation of the cervical spinal cord during structured rehabilitation. The clinical study was a prospective, single-arm, multicenter, open-label, non-significant risk trial, designed to assess the potential benefits of ARCEX Therapy in improving arm and hand functions in individuals with chronic cervical SCI. The primary endpoints focused on safety and efficacy, with efficacy determined by the improvement in both strength and functional performance of participants compared to an equivalent period of rehabilitation alone. The authors enrolled 60 participants with chronic cervical SCI in the trial, each undergoing at least 24 sessions of rehabilitation alone followed by 24 sessions of ARCEX Therapy. ARCEX Therapy involves the delivery of externally applied electrical stimulation over the cervical spinal cord. The stimulation was delivered using surface electrodes positioned above and below the injury site, with sessions conducted at 30 Hz with a 10 kHz carrier frequency overlay. The aim was to modulate the activity of the cervical spinal cord and facilitate improvements in arm and hand functions. The researchers reported no serious adverse events related to ARCEX Therapy with a total of 238 adverse events occurred, 44 being non-serious and related to ARCEX Therapy. The most common adverse event was muscle spasms, which were generally mild and not directly linked to the stimulation. They said the primary effectiveness endpoint was met, with 72% of participants demonstrating significant improvements in strength and functional performance. Improvements were observed in fingertip pinch force, hand prehension and strength, upper extremity motor and sensory abilities, and self-reported quality of life. The majority of participants (72%) met or exceeded the minimally important difference (MID) criteria for at least one strength and one functional performance outcome. Specific measures included the International Standards for Neurological Classification of Spinal Cord Injury-Upper Extremity Measurement Scale (ISNCSCI-UEMS), Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)-Strength, grasp force, and pinch force. Functional performance was assessed using the Capabilities of Upper Extremity Test (CUE-T) score and GRASSP-Prehension Performance. Moreover, secondary outcomes showed that ARCEX Therapy was superior to rehabilitation alone in improving responder rates. Significant improvements were noted in pinch force, GRASSP-Prehension Performance score, GRASSP-Strength score, ISNCSCI-UEMS, and total sensory score. Participants also reported enhanced quality of life, with improvements in the EuroQol five-dimensional five-level (EQ-5D-5L) scores.  Furthermore, exploratory analyses revealed additional benefits, including a reduction in the frequency of muscle spasms, improved sleep quality, and decreased pain levels. These findings further support the therapeutic potential of ARCEX Therapy in enhancing the overall well-being of individuals with chronic cervical SCI.

The authors’ findings demonstrate that ARCEX Therapy is a safe and effective intervention for improving arm and hand functions in people with chronic cervical SCI. The therapy not only facilitated significant improvements in strength and functional performance but also enhanced sensory function and quality of life. These results suggest that ARCEX Therapy could play a crucial role in the neurorehabilitation of individuals with SCI The exact mechanism by which ARCEX Therapy exerts its effects are believed to involve the growth of residual white matter tracts onto specific neuronal populations engaged by afferent pathways recruited by electrical stimulation. This reorganization is thought to be augmented by structured rehabilitation, leading to sustained neurological improvements even in the absence of ongoing stimulation. While structured rehabilitation alone can mediate improvements in functional domains, it generally does not result in significant changes in the underlying neurological status. In contrast, ARCEX Therapy was associated with improvements in both functional and neurological outcomes, suggesting that electrical stimulation can enhance the effectiveness of rehabilitation in promoting neurological recovery. The positive results of the Up-LIFT trial indicate that ARCEX Therapy could become a standard treatment for improving upper limb functions in individuals with chronic cervical SCI. The therapy’s safety profile and the significant functional gains observed suggest that it could be integrated into existing rehabilitation programs to augment recovery outcomes.

It will be interesting to conduct future research to better understand the long-term benefits of ARCEX Therapy and its potential application in other neurological conditions, such as stroke and Parkinson’s disease. Additionally, studies exploring the optimal timing and duration of ARCEX Therapy, as well as its mechanisms of action, will be essential for optimizing its clinical use. In conclusion, the Up-LIFT trial led by Professor Grégoire Courtine provides robust evidence supporting the safety and efficacy of ARCEX Therapy for improving arm and hand functions in people with chronic cervical SCI. The therapy’s ability to enhance strength, functional performance, and quality of life highlights its potential as a transformative treatment in neurorehabilitation. With further research and clinical application, ARCEX Therapy could significantly improve the lives of individuals living with SCI and other neurological disorders.