Evidence map›Paper›PMID 31182786›Full record

ArticleSpinal cord2019

Natural history of neurological improvement following complete (AIS A) thoracic spinal cord injury across three registries to guide acute clinical trial design and interpretation.

Alex A Aimetti, Steven Kirshblum, Armin Curt, Joseph Mobley, Robert G Grossman, James D Guest

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Spinal cord, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
5.2field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 2 countries.

Alex A AimettiInVivo Therapeutics Corporation, Cambridge, MA, USA.
Steven KirshblumKessler Institute and Rutgers University, West Orange, NJ, USA.
Armin CurtSpinal Cord Injury Center, Balgrist University Hospital, University of Zurich, Zurich, Switzerland.
Joseph MobleyDepartment of Neurological Surgery, University of Louisville, Louisville, KY, USA.
Robert G GrossmanDepartment of Neurosurgery, Houston Methodist Neurological Institute, Houston, TX, USA.
James D GuestDepartment of Neurosurgery, University of Miami, Miami, FL, USA. JGuest@med.miami.edu.
Houston Methodist · USKessler Institute for Rehabilitation · USUniversitätsklinik Balgrist · CHUniversity of Louisville · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designRetrospective, longitudinal analysis of motor and sensory outcomes following thoracic (T2-T12) sensorimotor complete spinal cord injury (SCI) in selected patients enrolled into three SCI) registries.

objectivesTo establish a modern-day international benchmark for neurological recovery following traumatic complete thoracic sensorimotor SCI in a population similar to those enrolled in acute clinical trials.

settingAffiliates of the North American Clinical Trial Network (NACTN), European Multicenter Study about Spinal Cord Injury (EMSCI), and the Spinal Cord Injury Model Systems (SCIMS).

methodsOnly traumatic thoracic injured patients between 2006 and 2016 meeting commonly used clinical trial inclusion/exclusion criteria such as: age 16-70, T2-T12 neurological level of injury (NLI), ASIA Impairment Scale (AIS) A, non-penetrating injury, acute neurological exam within 7 days of injury, and follow-up neurological exam at least ~ 6 months post injury, were included in this analysis. International Standards for Neurological Classification of Spinal Cord injury outcomes including AIS conversion rate, NLI, and sensory and motor scores/levels were compiled.

resultsA total of 170 patients were included from the three registries: 12 from NACTN, 64 from EMSCI, and 94 from SCIMS. AIS conversion rates at approximately 6 months post injury varied from 16.7% to 23.4% (21.1% weighted average). Improved conversion rates were observed in all registries for low thoracic (T10-T12) injuries when compared with high/mid thoracic (T2-T9) injuries. The NLI was generally stable and lower extremity motor score (LEMS) improvement was uncommon and usually limited to low thoracic injuries only.

conclusionsThis study presents the aggregation of selected multinational natural history recovery data in thoracic AIS A patients from three SCI registries and demonstrates comparable minimal improvement of ISNCSCI-scored motor and sensory function following these injuries, whereas conversions to higher AIS grades occur at a frequency of ~20%. These data inform the development of future clinical trial protocols in this important patient population for the interpretation of the safety and potential clinical benefit of new therapies, and the potential applicability in a multinational setting. SPONSORSHIP: InVivo Therapeutics.

Indexed as

RegistriesAdolescentAdultAgedClinical Trials as TopicFemaleHumansLongitudinal StudiesMaleMiddle AgedNeurologic ExaminationRecovery of FunctionRetrospective StudiesSpinal Cord InjuriesThoracic VertebraeTreatment Outcome

Identifiers

PMID31182786
PMCPMC6760562
OpenAlexW2948814292

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.