Evidence map›Paper›PMID 33165155›Full record

Trial reportThe Journal of head trauma rehabilitation

Safety Considerations for the Use of Transcranial Magnetic Stimulation as Treatment for Coma Recovery in People With Severe Traumatic Brain Injury.

Sandra L Kletzel, Alexandra L Aaronson, Ann Guernon, Christina Carbone, Noor Chaudhry, Elyse Walsh, Mark Conneely, Vijaya Patil, Elliott Roth, Monica Steiner and 3 more

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

Trial report in The Journal of head trauma rehabilitation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 12% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Review
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  4. Article
  5. Review
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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

13 authors at 2 institutions in 1 country.

Sandra L KletzelThe Department of Veterans Affairs (VA), Research Service, Edward Hines Jr VA Hospital, Hines, Illinois (Drs Kletzel, Aaronson, Guernon, Walsh, Patil, Steiner, Pacheco, and Bender Pape and Mr Chaudhry); The Department of Veterans Affairs Mental Health Service Line, Hines VA, Hines, Illinois (Dr Aaronson) Marianjoy Rehabilitation Hospital/Northwestern Medicine, Wheaton, Illinois (Drs Guernon and Bender Pape); Battle Creek VA Medical Center, Kalamazoo, Michigan (Dr Carbone); Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Drs Roth, Rosenow, and Bender Pape); Departments of Neurosurgery and Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Dr Rosenow); The Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine Chicago, Illinois (Drs Aaronson and Pacheco); Chicago Medical School, Rosalind Franklin University of Science and Medicine, North Chicago, Illinois, (Dr Conneely); Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois (Drs Patil and Steiner); University of Illinois at Chicago, Chicago, Illinois (Mr Chaudhry).
Alexandra L Aaronson
Ann Guernon
Christina Carbone
Noor Chaudhry
Elyse Walsh
Mark Conneely
Vijaya Patil
Elliott Roth
Monica Steiner
Marilyn Pacheco
Joshua Rosenow
Theresa L Bender Pape
Rudolf Steiner College · USEdward Hines, Jr. VA Hospital · US

Funding

Establishing Relationships and Developing a Therapeutic Target for Impulsivity and Suicidality Among Veterans with Traumatic Brain Injury and Co-occurring ConditionsIK1RX003082 · VA · EDWARD HINES JR VA HOSPITAL · PI AARONSON, ALEXANDRA LEIGH · 2020 to 2022
–
RRD VA IK1 RX001850RRD VA IK1 RX003082RRD VA IK2 RX002938
6 · The paper itself

Abstract

objectiveFor persons in states of disordered consciousness (DoC) after severe traumatic brain injury (sTBI), we report cumulative findings from safety examinations, including serious adverse events (AEs) of a repetitive transcranial magnetic stimulation (rTMS) parameter protocol in 2 different studies.

participantsSeven persons in states of DoC after sTBI with widespread neuropathology, but no large lesions in proximity to the site of rTMS. One participant had a ventriculoperitoneal shunt with programmable valve.

methodsTwo clinical trials each providing 30 rTMS sessions to the right or left dorsolateral prefrontal cortex, involving 300 to 600 pulses over 1 or 2 sessions daily. One study provided concomitant amantadine. Safety indicators monitored related to sleep, temperature, blood pressure, skin integrity, sweating, weight loss, infections, and seizure.

resultsAverage changes for monitored indicators were of mild severity, with 75 nonserious AEs and 1 serious AE (seizure). The participant incurring a seizure resumed rTMS while taking antieplieptics without further seizure activity.

conclusionsConsidering elevated risks for this patient population and conservative patient selection, findings indicate a relatively safe profile for the specified rTMS protocols; however, potential for seizure induction must be monitored. Future research for this population can be broadened to include patients previously excluded on the basis of profiles raising safety concerns.

Indexed as

Brain Injuries, TraumaticComaTranscranial Magnetic StimulationHumansPrefrontal CortexSeizuresTreatment Outcome

Identifiers

PMID33165155
PMCPMC8908773
OpenAlexW3095272112

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.