Albert Einstein Healthcare Network
No accepted clinical therapies exist for repair of motor pathways following spinal cord injury (SCI) in humans, leaving permanent disability and devastating personal and socioeconomic cost. A robust neural repair strategy has been demonstrated in preclinical studies, that is ready for translation to recovery of hand and arm function in human SCI, comprising daily transcranial magnetic stimulation treatment at the inpatient rehabilitation facility. This study will establish clinical effect size of the intervention, as well as safety and feasibility necessary for a subsequent controlled efficacy trial and inform preclinical studies for dosing optimization.
The objective of this proposal is to begin translating findings from pre-clinical studies to human motor deficits following cervical SCI (cervSCI). This HF-rTMS treatment protocol has not been previously assessed in human SCI and is qualitatively different from rTMS protocols reported to transiently modulate excitability of existing pathways, previously demonstrated in the literature. The protocol involves a daily stimulation of \~10 mins bilateral HF-rTMS for 2 weeks. SCI participants will be studied in a United States inpatient setting for this phase I study. Given the findings in the pre-c…
Inclusion Criteria: 1. Post traumatic or non-traumatic cervical spinal cord injury (SCI) with residual upper-extremity paralysis 2. Time post-injury less than six weeks 3. Neurological Level of Injury (NLI) C4-C6 4. ASIA Impairment Scale (AIS) A-D 5. Sensory and motor zone of partial preservation (ZPP, clinically complete or incomplete) 6. Age 18 to 80 years old Exclusion Criteria: 1. Ventilator dependence; 2. Concurrent neurological condition affecting sensory or motor pathways or otherwise limiting ability to participate in the study; 3. Evidence of trauma-related brain injury; 4. Contrai…
The stimulation protocol will comprise 15Hz pulse trains, each 50 pulses, repeated 10x, with a 60s inter-train interval. Stimulation intensity will be determined from individual MRI-modeled e-field, to achieve approximately motor threshold in the target area.
The stimulation protocol will comprise 15Hz pulse trains, each 50 pulses, repeated 10x, with a 60s inter-train interval. Stimulation intensity will be close to zero (negligible) since sham coil will be used for the intervention
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