Table 3.
Approaches Used in Acute/Subacute Spinal Cord Injury
| Study | Study phase | Approach | Classification | Mechanism | Outcome measure/effect (clinical neurological and/or motor performance) | Comparison/control | Direction of results | Follow-up | CS integrity | CS connectivity |
|---|---|---|---|---|---|---|---|---|---|---|
| Fehlings et al, 2011 | Phase I | Cethrin | Pharmacology | ↓ excitoxicity | AIS scores | N/A | N/A | 12 months | MRI | Absent |
| Chen et al, 2005 | Phase I | Raffinee | Pharmacology | ↓ excitoxicity | AIS scores | N/A | N/A | 2–3 weeks | Absent | Absent |
| Shapiro et al, 2005 | Phase I | Implanted oscillating electric field | Electrical stimulation/neuroelectric device | Neural guidance | AIS scores | N/A | N/A | 6 months, 12 months | MRI-excluded complete injuries | Absent |
| Park et al, 2005 | Phase I | Bone-marrow derived mesenchymal stromal cells | Cell therapy | Neural regeneration | AIS scores | N/A | N/A | 6–18 months | MRI-excluded complete injuries | Absent |
| Zhou et al, 2012 | Phase I | Autologous activated Schwann cells | Cell therapy | Neural regeneration | AIS scores, FIM | N/A | N/A | 15–18 weeks, 5–8 years | MRI | MEPs (post-test) |
| Knoller et al, 2005 | Phase I | Autologous macrophages | Cell therapy | Neural regeneration | AIS scores | N/A | N/A | 4–12 months | MRI | MEPs |
| Grossman et al, 2014 | Phase II | Riluzole | Pharmacology | ↓ excitoxicity | AIS motor scores,* SCIM | Database control | * = ↑ Riluzole | 42 days, 3 months, 6 months* | Absent | Absent |
| Takahashi et al, 2012 | Phase II | G-CSF | Pharmacology | ↓ excitoxicity | AIS motor scores† | Database control | † = ↑ (G-CSF) | 3 months | Absent | Absent |
| Casha et al, 2012 | Phase III | Minocycline | Pharmacology | ↓ excitoxicity | AIS scores, FIM, and SCIM | Placebo | No differences | 3, 6, and 12 months | Absent | Absent |
| Inada et al, 2014 | Phase II | G-CSF | Pharmacology | ↓ excitoxicity | AIS motor scores* | Control (no intervention) | * = ↑ (G-CSF) | 1 year | Absent | Absent |
| Kumru et al, 2013 | Phase III | High-frequency rTMS | Combination of electrical stimulation/neuroelectric device + rehabilitation | Plasticity | Gait speed† and LEMS (AIS)† | Sham-rTMS + rehabilitation | † = ↑ rTMS + rehabilitation | 5 weeks | Absent | MEPs |
| Alcobendas-Maestro et al, 2012 | Phase III | Locomotor training (overground vs. robotic orthosis) | Rehabilitation | Plasticity | FIM,† WISCI,† walking distance† and LEMS (AIS)†, walking speed | Overground locomotor training | † = ↑ robotic orthosis | 8 weeks | Absent | Absent |
| Dobkin et al, 2007 | Phase III | Locomotor training (overground vs. treadmill) + Physical therapy, nursing | Combination of rehabilitation+ nursing | Plasticity | Walking speed | Overground locomotor training | No differences | 9 weeks | Absent | Absent |
| Wong et al, 2013 | Phase III | Electrical and auricular acupuncture + rehabilitation | Combination of rehabilitation techniques | Unknown | AIS scores, Ffunctional Independence Measure† | Rehabilitation in isolation | † = ↑rehab + acupuncture | 12 months | Absent | Absent |
| Li et al, 2012 | Phase III | DHYZ | Pharmacology | Unknown | AIS scores* | Placebo | * = ↑ DHYZ group | 12 weeks | Absent | Absent |
| Maric et al, 2009 | Phase III | L-Dopa | Pharmacology | Plasticity | AIS scores, FIM, WISCI | Placebo | No differences | 12 weeks | Absent | Absent |
Refers to between-group differences and †refers to pre-post differences.
Phase I studies do not include a control/comparison group and do not assess effectiveness (direction of results); therefore, these items have been noted as applicable (N/A).
AIS, American Spinal Cord Injury Impairment Scale; MRI, magnetic resonance imaging; MEP, motor evoked potentials; SCIM, Spinal Cord Independence Measure; G-CSF, granulocyte colony-stimulating factor; FIM, Functional Independence Measure; rTMS, repetitive transcranial magnetic stimulation; LEMS, lower extremity motor scores obtained from AIS assessment; WISCI, walking index for spinal cord injury; DHYZ, Di Huang Yin Zi, a traditional Chinese medicine.