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Re-inventing yourself after spinal cord injury: a site-specific randomized clinical trial.

ABSTRACT: STUDY DESIGN:Parallel-arm randomized controlled trial comparing an interactive group format versus a no-intervention control. OBJECTIVE:To evaluate the efficacy of a replicable group treatment program for improving self-efficacy after spinal cord injury (SCI) in a single center cohort of adults. SETTING:Regional SCI center. METHODS:Participants included 81 individuals with SCI who were at least 4 weeks post-discharge from initial rehabilitation. Those randomized to treatment participated in six interactive learning sessions (2?hours each, one session per week) with structured and facilitated group interactions to improve self-efficacy. A wait-list control group was followed at matching time points for all outcome measures. The primary outcome measure was the Moorong Self-Efficacy Scale (MSES); secondary outcomes were the Generalized Self-Efficacy Scale (GSES); Diener Satisfaction with Life Scale (SWLS); Participation Assessment with Recombined Tools - Objective (PART-O); Patient Health Questionnaire - 9 (PHQ-9); and General Anxiety Disorder 7-item (GAD-7). RESULTS:Individuals in the Treatment group had greater increases in MSES scores from baseline to immediately post-intervention (6 weeks) than the Control group, but that difference did not remain significant after controlling for multiple comparisons. However, the improvement in the treatment group relative to the control group was not maintained through follow-up at 30 weeks. There was no evidence of an immediate or sustained treatment effect on any of the secondary outcomes. CONCLUSIONS:Self-efficacy improved for participants with SCI in the Treatment group, however, this improvement was not significant or maintained on follow-up.

SUBMITTER: Coker J

PROVIDER: S-EPMC6451659 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Re-inventing yourself after spinal cord injury: a site-specific randomized clinical trial.

Coker Jennifer J Cuthbert Jeffrey J Ketchum Jessica M JM Holicky Richard R Huston Toby T Charlifue Susan S

Spinal cord 20181220 4

<h4>Study design</h4>Parallel-arm randomized controlled trial comparing an interactive group format versus a no-intervention control.<h4>Objective</h4>To evaluate the efficacy of a replicable group treatment program for improving self-efficacy after spinal cord injury (SCI) in a single center cohort of adults.<h4>Setting</h4>Regional SCI center.<h4>Methods</h4>Participants included 81 individuals with SCI who were at least 4 weeks post-discharge from initial rehabilitation. Those randomized to t ...[more]

PMID: 30573769

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Project description:Attenuation of the secondary injury of spinal cord injury (SCI) can suppress the spread of spinal cord tissue damage, possibly resulting in spinal cord sparing that can improve functional prognoses. Granulocyte colony-stimulating factor (G-CSF) is a haematological cytokine commonly used to treat neutropenia. Previous reports have shown that G-CSF promotes functional recovery in rodent models of SCI. Based on preclinical results, we conducted early phase clinical trials, showing safety/feasibility and suggestive efficacy. These lines of evidence demonstrate that G-CSF might have therapeutic benefits for acute SCI in humans. To confirm this efficacy and to obtain strong evidence for pharmaceutical approval of G-CSF therapy for SCI, we conducted a phase 3 clinical trial designed as a prospective, randomized, double-blinded and placebo-controlled comparative trial. The current trial included cervical SCI [severity of American Spinal Injury Association (ASIA) Impairment Scale (AIS) B or C] within 48 h after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group was administered 400 μg/m2/day × 5 days of G-CSF in normal saline via intravenous infusion for five consecutive days. The placebo group was similarly administered a placebo. Allocation was concealed between blinded evaluators of efficacy/safety and those for laboratory data, as G-CSF markedly increases white blood cell counts that can reveal patient treatment. Efficacy and safety were evaluated by blinded observer. Our primary end point was changes in ASIA motor scores from baseline to 3 months after drug administration. Each group includes 44 patients (88 total patients). Our protocol was approved by the Pharmaceuticals and Medical Device Agency in Japan and this trial is funded by the Center for Clinical Trials, Japan Medical Association. There was no significant difference in the primary end point between the G-CSF and the placebo control groups. In contrast, one of the secondary end points showed that the ASIA motor score 6 months (P = 0.062) and 1 year (P = 0.073) after drug administration tend to be higher in the G-CSF group compared with the placebo control group. Moreover, in patients aged over 65 years old, motor recovery 6 months after drug administration showed a strong trend towards a better recovery in the G-CSF treated group (P = 0.056) compared with the control group. The present trial failed to show a significant effect of G-CSF in primary end point although the subanalyses of the present trial suggested potential G-CSF benefits for specific population.

Project description:ImportanceIndividuals with spinal cord injury (SCI) have significant autonomic nervous system dysfunction. However, despite recent findings postulated to support that spinal cord stimulation improves dynamic autonomic regulation, limited scope of previous testing means the true effects remain unknown.ObjectiveTo determine whether transcutaneous spinal cord stimulation improves dynamic autonomic regulation after SCI.DesignSingle-blinded, randomized crossover trial with matched cohorts.SettingAcademic autonomic physiology laboratory.ParticipantsTwo pairs of well-matched individuals with and without high-thoracic, complete SCI.InterventionsSub-motor threshold transcutaneous spinal cord stimulation delivered at T10-T11 using 120Hz, 30Hz, and 30Hz with 5kHz carrier frequency at separate autonomic testing sessions.Main outcomes and measuresBaseline autonomic regulation was characterized with tests of above injury level sympathoexcitation (Valsalva's maneuver), sympathoinhibition (progressive doses of bolus intravenous phenylephrine), and below level sympathoexcitation (foot cold pressor test). At three subsequent visits, this testing battery was repeated with the addition of spinal cord stimulation at each frequency. Changes in autonomic regulation for each frequency were then analyzed relative to baseline testing for each individual and within matched cohorts.ResultsUninjured controls demonstrated no autonomic deficits at baseline and had no changes with any frequency of stimulation. Contrasting this, and as expected, individuals with SCI had baseline autonomic dysfunction. In a frequency-dependent manner, spinal cord stimulation enhanced sympathoexcitatory responses, normalizing previously impaired Valsalva's maneuvers. However, stimulation exacerbated already impaired sympathoinhibitory responses, resulting in significantly greater mean arterial pressure increases with the same phenylephrine doses compared to baseline. Impaired sympathoexcitatory response below the level of injury were also further exacerbated with spinal cord stimulation. At baseline, neither individual with SCI demonstrated autonomic dysreflexia with the noxious foot cold pressor test; the addition of stimulation led to a dysreflexic response in every trial, with greater relative hypertension and bradycardia indicating no improvement in autonomic regulation.Conclusions and relevanceTranscutaneous spinal cord stimulation does not improve autonomic regulation after SCI, and instead likely generates tonic, frequency-dependent sympathoexcitation which may lower the threshold for autonomic dysreflexia.

Project description:The purpose of the present study was to examine the efficacy of targeting inflammation as a means of improving mood following spinal cord injury (SCI) and explore the potential mechanisms of action.The study was a randomized, parallel-group, controlled, clinical trial (NCT02099890) whereby 20 participants with varying levels and severities of SCI were randomized (3:2) to either the treatment group, consisting of a 12-week anti-inflammatory diet, or control group. Outcome measures were assessed at baseline, 1 and 3 months, and consisted of CES-D scores of depression, markers of inflammation as assessed by various pro- and anti-inflammatory cytokines and several amino acids related to depression.A significant group × time interaction was found for CES-D (Center for Epidemiologic studies Depression Scale) score (p?=?0.01), the TRP/LNAA (tryptophan/large neutral amino acid) ratio (p?=?0.04), the composite score of pro-inflammatory cytokines (p?=?0.04), IL-1? (interleukin-1 beta) (p?=?0.04), and IFN-? (interferon gamma) (p?=?0.03). Pearson's r correlation showed significance between the ?IL-1? and both the ?CES-D score (r?=?0.740, p?<?0.01) and the ?KYN/TRP (kynurenine/tryptophan) ratio (r?=?0.536, p?=?0.02). The ?KYN/TRP ratio was also significantly correlated with the ?CES-D score (r?=?0.586, p?=?0.01). Mediation analysis showed that the relationship between the ?KYN/TRP ratio and the ?CES-D score was mediated by the ?IL-1?. Subgroup analysis showed that participants with high CES-D scores had significantly higher concentrations of IL-1?, and all correlations were maintained or strengthened within this subgroup.Overall, the results demonstrated the effectiveness of targeting inflammation as a means of improving mood in SCI, with potential mechanisms relating to the reduction in IL-1? and improvements in levels of neuroactive compounds related to the kynurenine pathway. Due to the limited sample size, results should be interpreted with caution; however, they are worthy of further examination due to the potential impact of inflammation on depression.ClinicalTrials.gov ID: NCT02099890 .

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Re-inventing yourself after spinal cord injury: a site-specific randomized clinical trial.

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Re-inventing yourself after spinal cord injury: a site-specific randomized clinical trial.

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